{ "schemaVersion": 1, "datasetId": "ki-medizinproduktmonitor-eu", "generatedAt": "2026-08-12T14:17:00.000Z", "lastCheckedAt": "2026-08-12T14:17:00.000Z", "trackingSince": "2026-07-23", "dateModified": "2026-08-12", "materialFingerprint": "09fc8ec4c411091323316b53356f20d9d596d3ddb23c985ca986bd11274a4777", "observationFingerprint": "dbd370054fd3744a96f23b5111be36c19767a1e87656a42d8008419f7427c0c8", "collection": { "mode": "verified-private-archive-projection", "completed": true, "revision": 242, "pages": 6, "reviewedSoftwareRecords": 5532, "removedSoftwareRecords": 14, "softwareTypes": [ { "id": "-47", "value": "Software" }, { "id": "-43", "value": "Software" } ], "firstObservedAt": "2026-07-23T07:56:24.538Z", "lastObservedAt": "2026-08-12T14:17:00.000Z" }, "coverage": { "geography": "European Union", "module": "UDI/Devices", "cohort": "EUDAMED devices whose SPECIAL_DEVICE_TYPE_ID resolves exactly to Software", "candidates": "Only records with exact source-text AI evidence" }, "claimBoundary": { "certificatesExposed": false, "marketSurveillanceExposed": false, "sourceChangeDatesAvailable": false, "aiInferenceUsed": false }, "lifecycle": { "timeBasis": "collector_observation", "sourceChangeDatesAvailable": false, "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "totalEventCount": 30, "materialChangeEventCount": 29, "retainedEventCount": 21, "truncated": true, "events": [ { "id": "event-23cf99648c6fca32a977a0b0", "type": "baseline_observed", "revision": 1, "observedAt": "2026-07-23T11:03:00.000Z", "timeBasis": "collector_observation", "counts": { "reviewedSoftwareRecords": 5363, "candidates": 82, "manufacturers": 44 } }, { "id": "event-97d5859a0ffb5e749b02dfd8", "type": "software_corpus_summary_changed", "revision": 81, "observedAt": "2026-07-30T02:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 83, "candidatesBefore": 83, "reviewedSoftwareRecordsAfter": 5415, "reviewedSoftwareRecordsBefore": 5420 } }, { "id": "event-75e5689c59b3ecfa3a5ee70d", "type": "device_added", "revision": 92, "observedAt": "2026-07-31T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "device", "id": "device-ab75f71543516a1d", "label": "Shen.AI" } }, { "id": "event-05d39d9d03184ee183bf5b5f", "type": "software_corpus_summary_changed", "revision": 93, "observedAt": "2026-07-31T02:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 84, "candidatesBefore": 84, "reviewedSoftwareRecordsAfter": 5424, "reviewedSoftwareRecordsBefore": 5431 } }, { "id": "event-e02ff41f5daf604cabff60c5", "type": "software_corpus_summary_changed", "revision": 105, "observedAt": "2026-08-01T02:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 84, "candidatesBefore": 84, "reviewedSoftwareRecordsAfter": 5441, "reviewedSoftwareRecordsBefore": 5431 } }, { "id": "event-06540c8f99a27686f5d8fe46", "type": "software_corpus_summary_changed", "revision": 141, "observedAt": "2026-08-04T02:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 84, "candidatesBefore": 84, "reviewedSoftwareRecordsAfter": 5452, "reviewedSoftwareRecordsBefore": 5448 } }, { "id": "event-da2a3f4c307d94a6fbe11ae1", "type": "software_corpus_summary_changed", "revision": 142, "observedAt": "2026-08-04T04:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 84, "candidatesBefore": 84, "reviewedSoftwareRecordsAfter": 5452, "reviewedSoftwareRecordsBefore": 5460 } }, { "id": "event-41b7b8ab631842af51b74d77", "type": "software_corpus_summary_changed", "revision": 152, "observedAt": "2026-08-05T00:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 84, "candidatesBefore": 84, "reviewedSoftwareRecordsAfter": 5461, "reviewedSoftwareRecordsBefore": 5460 } }, { "id": "event-27e29323219dcc2a64851905", "type": "device_removed_after_two_complete_misses", "revision": 153, "observedAt": "2026-08-05T02:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "device", "id": "device-4bd2d18bd178dc66", "label": "VUNO Med-LungCT AI" } }, { "id": "event-2165f69f88285b5f3d91c8fd", "type": "software_corpus_summary_changed", "revision": 164, "observedAt": "2026-08-06T00:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 83, "candidatesBefore": 83, "reviewedSoftwareRecordsAfter": 5471, "reviewedSoftwareRecordsBefore": 5472 } }, { "id": "event-6618163febad1555fa30e2b5", "type": "software_corpus_summary_changed", "revision": 176, "observedAt": "2026-08-07T00:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 83, "candidatesBefore": 83, "reviewedSoftwareRecordsAfter": 5475, "reviewedSoftwareRecordsBefore": 5482 } }, { "id": "event-417a15f2297d6383bffccc0d", "type": "software_corpus_summary_changed", "revision": 177, "observedAt": "2026-08-07T02:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 83, "candidatesBefore": 83, "reviewedSoftwareRecordsAfter": 5475, "reviewedSoftwareRecordsBefore": 5489 } }, { "id": "event-12811787798287b047e5016d", "type": "device_record_changed", "revision": 188, "observedAt": "2026-08-08T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "device", "id": "device-7e9a5450c9998f67", "label": "ZEISS AI IOL Calculator" }, "fields": [ "TRADE_NAME" ] }, { "id": "event-62e9a15e481f4620f2d6b3f5", "type": "device_ai_evidence_changed", "revision": 188, "observedAt": "2026-08-08T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "device", "id": "device-7e9a5450c9998f67", "label": "ZEISS AI IOL Calculator" }, "fields": [ "aiEvidence" ] }, { "id": "event-ad751045a6b941220c853d3e", "type": "manufacturer_status_changed", "revision": 188, "observedAt": "2026-08-08T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "manufacturer", "id": "manufacturer-1bedb459c02ba1", "label": "Siemens Healthineers AG" }, "fields": [ "VERSION" ] }, { "id": "event-c230dc8eb0fe005ac0c2fda8", "type": "manufacturer_status_changed", "revision": 188, "observedAt": "2026-08-08T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "manufacturer", "id": "manufacturer-c1198e8391a360", "label": "Siemens Healthcare GmbH" }, "fields": [ "VERSION" ] }, { "id": "event-e37a4962474fd5cad991b612", "type": "device_version_changed", "revision": 188, "observedAt": "2026-08-08T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "device", "id": "device-7e9a5450c9998f67", "label": "ZEISS AI IOL Calculator" }, "fields": [ "VERSION_NUMBER" ] }, { "id": "event-9d7d31bb1aff9b461f02f7b2", "type": "software_corpus_summary_changed", "revision": 200, "observedAt": "2026-08-09T00:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 83, "candidatesBefore": 83, "reviewedSoftwareRecordsAfter": 5503, "reviewedSoftwareRecordsBefore": 5516 } }, { "id": "event-d62fa3a5aa7fba5a728aefc8", "type": "software_corpus_summary_changed", "revision": 213, "observedAt": "2026-08-10T02:17:00.000Z", "timeBasis": "collector_observation", "counts": { "candidatesAfter": 83, "candidatesBefore": 83, "reviewedSoftwareRecordsAfter": 5504, "reviewedSoftwareRecordsBefore": 5517 } }, { "id": "event-ba7b3d68d4b8ed1c5a4b3e41", "type": "manufacturer_status_changed", "revision": 224, "observedAt": "2026-08-11T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "manufacturer", "id": "manufacturer-0a3f55cd11893f", "label": "Noteless AS" }, "fields": [ "VERSION" ] }, { "id": "event-a413eb7e51dc85d63015b0cd", "type": "device_added", "revision": 235, "observedAt": "2026-08-12T00:17:00.000Z", "timeBasis": "collector_observation", "subject": { "kind": "device", "id": "device-3163903c96083ed6", "label": "DR. INFO" } } ] }, "counts": { "reviewedSoftwareRecords": 5532, "removedSoftwareRecords": 14, "candidates": 84, "removedCandidates": 1, "manufacturers": 47, "explicit": 2, "contextualAiToken": 52, "brandOnly": 30, "active": 71 }, "devices": [ { "id": "device-dc75f8e9aa21f65f", "title": "AccuContour AI-assisted Auto-contouring Tool", "primaryDi": "06973127400029", "basicUdi": "697312740AccuContourXE", "manufacturer": { "srn": "CN-MF-000023911", "name": "Manteia Technologies Co., Ltd.", "countryCode": "CN" }, "tradeName": "AccuContour", "deviceName": "AccuContour AI-assisted Auto-contouring Tool", "deviceModel": "AccuContour", "reference": "AC0029", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11010492", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "AccuContour AI-assisted Auto-contouring Tool", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "f886c08d274356383bb1f3bf12c63bb861442d7c0824e845695400daaf9b52d6" }, { "id": "device-e062394bebb9003e", "title": "AccuContour AI-assisted Auto-contouring Tool", "primaryDi": "06973127400050", "basicUdi": "697312740AccuContourLTQ3", "manufacturer": { "srn": "CN-MF-000023911", "name": "Manteia Technologies Co., Ltd.", "countryCode": "CN" }, "tradeName": "AccuContour-Lite", "deviceName": "AccuContour AI-assisted Auto-contouring Tool", "deviceModel": "AccuContour-Lite", "reference": "AC0050", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11010492", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "AccuContour AI-assisted Auto-contouring Tool", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "241c6fdf8a31d1af4ab5df96e70fc6d6299cfa9e02cd1c02932cb375b4a19568" }, { "id": "device-5ef2d2940b94e654", "title": "AI Contouring Family", "primaryDi": "04068151048117", "basicUdi": "0405686902368W2", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI Contouring", "deviceName": "AI Contouring Family", "deviceModel": "AI Contouring Family", "reference": "10831446", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "AI Contouring Family", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "AI Contouring Family", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI Contouring", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "007d2be883f346813401f57b5e84399437446dd9ba1c6abcd8cecf2c844c35ef" }, { "id": "device-2d96b3120f677558", "title": "AI DWI Mismatch V1.0", "primaryDi": "+EOLEAIDMV1P00", "basicUdi": "++EOLEAIDM72", "manufacturer": { "srn": "FR-MF-000002403", "name": "Olea Medical S.A.S.", "countryCode": "FR" }, "tradeName": "AI DWI Mismatch V1.0", "deviceName": "AI DWI Mismatch V1.0", "deviceModel": null, "reference": "AP-NV-AIDM-MR", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11050182", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "AI DWI Mismatch V1.0", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI DWI Mismatch V1.0", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "b42e9f2d071aa339140ac3c3b091213d24879726b7d4bc72ee8a4c85fa1e36f1" }, { "id": "device-73d76258ad864932", "title": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "primaryDi": "06429810612076", "basicUdi": "06429810612BR004KE", "manufacturer": { "srn": "FI-MF-000008986", "name": "Aiforia Technologies Plc", "countryCode": "FI" }, "tradeName": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "deviceName": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "deviceModel": null, "reference": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "medicalPurpose": null, "riskClassId": -201, "riskClass": "Class C", "legislationId": -198, "legislation": "IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)", "nomenclatureCode": "W0202050392", "deviceCriterion": "STANDARD", "softwareTypeId": "-47", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": null, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "KIT": 0, "STERILE": 0, "SELF_TESTING": 0, "REAGENT": 0, "INSTRUMENT": 0, "PROFESSIONAL_TESTING": 1, "NEAR_PATIENT_TESTING": 0, "COMPANION_DIAGNOSTICS": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "tier": "contextual_ai_token" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Aiforia® Clinical AI Model for Breast Cancer - HER2", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "fdd7c699bd466c05e6eae40918ba27f2cbf634e78c86dc7283882f767af0dac5" }, { "id": "device-c7038645caf73d03", "title": "Allisone AI", "primaryDi": "03770024648065", "basicUdi": "3770024648ALSN0019R", "manufacturer": { "srn": "FR-MF-000020951", "name": "ALLISONE TECHNOLOGIES", "countryCode": "FR" }, "tradeName": null, "deviceName": "Allisone AI", "deviceModel": "V2", "reference": "V2.5.5", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Allisone AI", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "65d84ad9142c2014a153452502f2e38d1494ef83bd8c65995b67f39733330adb" }, { "id": "device-fea6aefe0b314626", "title": "Altris AI", "primaryDi": "00860009826502", "basicUdi": "0860009826527W", "manufacturer": { "srn": "US-MF-000043686", "name": "Altris Inc.", "countryCode": "US" }, "tradeName": "Altris", "deviceName": "Altris AI", "deviceModel": "Altris AI v2.1.1", "reference": "1", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12120182", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Altris AI", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Altris AI v2.1.1", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "220314edbc06b65edd2299110bb18e739244d6d1d815d3b19d6acd46d0374b35" }, { "id": "device-125048fce75128f0", "title": "Annotation Tool", "primaryDi": "+G841BPAIT0011-", "basicUdi": "++G841PRAIDAIANNOTATIONE3", "manufacturer": { "srn": "PK-MF-000052649", "name": "BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED", "countryCode": "PK" }, "tradeName": "PRAID AI Annotation Tool", "deviceName": "Annotation Tool", "deviceModel": "BPAI-T001", "reference": "BPAI-T001", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "PRAID AI Annotation Tool", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "3bd13535317f8212977b2836a2d8ce43bad77a48baf9453c81a67c9a9c95436c" }, { "id": "device-fcf8c621a3f8c757", "title": "Autismikysely", "primaryDi": "06438300000033", "basicUdi": "6438300ASQDV", "manufacturer": { "srn": "FI-MF-000007401", "name": "HUS-yhtymä", "countryCode": "FI" }, "tradeName": "Autismikysely", "deviceName": "Autismikysely", "deviceModel": null, "reference": "AI-00002894", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "REFERENCE", "term": "AI", "sourceText": "AI-00002894", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "9c46d18012825dde426827866c1373b66e6954991e301a1b2ac87e00b7975a77" }, { "id": "device-c1a343f3e8376225", "title": "CADDIE - AI software for the analysis of endoscopic video images", "primaryDi": "15065010840000", "basicUdi": "5065010840OD01P9", "manufacturer": { "srn": "GB-MF-000026653", "name": "Odin Medical Limited", "countryCode": "UK" }, "tradeName": "CADDIE", "deviceName": "CADDIE - AI software for the analysis of endoscopic video images", "deviceModel": null, "reference": "CADDIE", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "G99", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "CADDIE - AI software for the analysis of endoscopic video images", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "d151b22cd54e56b5244f0e91900817ef9be57915b9988ce5a5513bfd3cfe3f81" }, { "id": "device-3dd03c3634a30ddc", "title": "CADDIE PLUS - AI software for the analysis of endoscopic video images", "primaryDi": "05065010840041", "basicUdi": "5065010840OD07PM", "manufacturer": { "srn": "GB-MF-000026653", "name": "Odin Medical Limited", "countryCode": "UK" }, "tradeName": "CADDIE PLUS", "deviceName": "CADDIE PLUS - AI software for the analysis of endoscopic video images", "deviceModel": null, "reference": "CADDIE PLUS", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "G99", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "CADDIE PLUS - AI software for the analysis of endoscopic video images", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "d3878d7fe34033088fc0d93fe331fbafcde1d387a237531abc93488601723c01" }, { "id": "device-07b2db3a14067d57", "title": "CADU - AI software for the analysis of endoscopic video images", "primaryDi": "15065010840017", "basicUdi": "5065010840OD02PB", "manufacturer": { "srn": "GB-MF-000026653", "name": "Odin Medical Limited", "countryCode": "UK" }, "tradeName": "CADU", "deviceName": "CADU - AI software for the analysis of endoscopic video images", "deviceModel": null, "reference": "CADU", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "G99", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 3, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "CADU - AI software for the analysis of endoscopic video images", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "7852246e82129123098582bd51fa886b1fe90338b98569973431d043b42ded6b" }, { "id": "device-20d43597a5513197", "title": "Caption AI", "primaryDi": "00198953030233", "basicUdi": "08406821BUG005477K", "manufacturer": { "srn": "US-MF-000016119", "name": "GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC", "countryCode": "US" }, "tradeName": "Caption AI", "deviceName": "Caption AI", "deviceModel": "5700645", "reference": "5984922", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11040182", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Caption AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Caption AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "7894a1476f6ace88a07bd9b5a53494ef892c586eef4d06d3766822a42b20b223" }, { "id": "device-c5c8a0519033dc0e", "title": "Caption AI", "primaryDi": "00198953038604", "basicUdi": "08406821BUG005477K", "manufacturer": { "srn": "US-MF-000016119", "name": "GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC", "countryCode": "US" }, "tradeName": "Caption Guidance", "deviceName": "Caption AI", "deviceModel": "5700645", "reference": "5700635", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11040182", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Caption AI", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "2c3303fd5a111a0cc2dfb0ca7285767f81626f37210536a5d39a75bb87bb08c6" }, { "id": "device-f68123d73ee332ad", "title": "Caption AI on vScan", "primaryDi": "00860003586341", "basicUdi": "08600035863VSCAISM", "manufacturer": { "srn": "US-MF-000022891", "name": "Caption Health, Inc.", "countryCode": "US" }, "tradeName": null, "deviceName": null, "deviceModel": "Caption AI on vScan", "reference": "511-00022", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11040182", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1307, "status": "Inactive", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Caption AI on vScan", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "8260133e03a0ad5ea4a2e20e8bd54be52fd9a21ce7190db6590e11a09d90fa3a" }, { "id": "device-4dd543db49de1d2a", "title": "Central Monitoring System", "primaryDi": "06941900602472", "basicUdi": "69419006CMSPM0101DU", "manufacturer": { "srn": "CN-MF-000009430", "name": "Shenzhen Creative Industry Co., Ltd.", "countryCode": "CN" }, "tradeName": null, "deviceName": "Central Monitoring System", "deviceModel": "AI-ECG Monitor、PC-1000A", "reference": "PC-1000A", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z1203020292", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "AI-ECG Monitor、PC-1000A", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "da1c1c2e8efbcb1dc8921a447c8c44bfce9df59efc3fc7cd7b6254ae258beb43" }, { "id": "device-c31b417ad0fb605e", "title": "Central Monitoring System", "primaryDi": "06941900602519", "basicUdi": "69419006CMSPM0101DU", "manufacturer": { "srn": "CN-MF-000009430", "name": "Shenzhen Creative Industry Co., Ltd.", "countryCode": "CN" }, "tradeName": null, "deviceName": "Central Monitoring System", "deviceModel": "AI-ECG Monitor、PC-1000A", "reference": "AI-ECG Monitor", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z1203020292", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "AI-ECG Monitor、PC-1000A", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "AI-ECG Monitor", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "2beafec087557114aed3ff2f24d9b8978395e9aebefe3d14ed2e7f6918244aa4" }, { "id": "device-d765eaf4fa4cc222", "title": "Contour+ (MVision AI Segmentation)", "primaryDi": "06429830064206", "basicUdi": "64298300642AISEG1.2SZ", "manufacturer": { "srn": "FI-MF-000013082", "name": "MVision AI Oy", "countryCode": "FI" }, "tradeName": "Contour+ (MVision AI Segmentation)", "deviceName": "Contour+ (MVision AI Segmentation)", "deviceModel": "Contour+ (MVision AI Segmentation) 1.2", "reference": "Contour+ (MVision AI Segmentation)", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11010292", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Contour+ (MVision AI Segmentation)", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Contour+ (MVision AI Segmentation) 1.2", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Contour+ (MVision AI Segmentation)", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Contour+ (MVision AI Segmentation)", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "ef85f8828032a9b71d9500e10559165a3248d982f1e9597f2771a580c5b5c1cc" }, { "id": "device-357122c81ddbcf4e", "title": "Deep Learning Image Reconstruction", "primaryDi": "00195278620453", "basicUdi": "8406821BUG00032GR", "manufacturer": { "srn": "JP-MF-000009291", "name": "GE Healthcare Japan Corporation", "countryCode": "JP" }, "tradeName": "Deep Learning Image Reconstruction", "deviceName": "Deep Learning Image Reconstruction", "deviceModel": "ver 1.1, ver 1.2", "reference": "5928863", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11030682", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 3, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "deep learning", "sourceText": "Deep Learning Image Reconstruction", "tier": "explicit" }, { "field": "TRADE_NAME", "term": "deep learning", "sourceText": "Deep Learning Image Reconstruction", "tier": "explicit" } ], "evidenceTier": "explicit", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "c769ad2cd7411895edb034aec3dbda85d7b17742d67e6447ed403f3e1403babf" }, { "id": "device-eab2e88b9034882a", "title": "Deep Learning Image Reconstruction", "primaryDi": "00195278303202", "basicUdi": "8406821BUG00032GR", "manufacturer": { "srn": "JP-MF-000009291", "name": "GE Healthcare Japan Corporation", "countryCode": "JP" }, "tradeName": "Deep Learning Image Reconstruction", "deviceName": "Deep Learning Image Reconstruction", "deviceModel": "ver 1.1, ver 1.2", "reference": "5869275", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11030692", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 3, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "deep learning", "sourceText": "Deep Learning Image Reconstruction", "tier": "explicit" }, { "field": "TRADE_NAME", "term": "deep learning", "sourceText": "Deep Learning Image Reconstruction", "tier": "explicit" } ], "evidenceTier": "explicit", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "a161bd21e7a783340dda31ef244ef768f701f854cbd258f015c47309e1cb4c7d" }, { "id": "device-f03489920bff0649", "title": "DeepTek CXR AI", "primaryDi": "08908023670014", "basicUdi": "8908023670DT0032K", "manufacturer": { "srn": "IN-MF-000040297", "name": "DeepTek Medical Imaging Private Limited", "countryCode": "IN" }, "tradeName": null, "deviceName": "DeepTek CXR AI", "deviceModel": null, "reference": "DeepTek_003", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "DeepTek CXR AI", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "39c19fdb48147d5853c9a8b8cc74d2c7f3bb816611d43032c2e8cdd958a9d4d0" }, { "id": "device-da3ef73d061908e6", "title": "Dental AI", "primaryDi": "04262458810006", "basicUdi": "4262458810006Y5", "manufacturer": { "srn": "DE-MF-000040431", "name": "synMedico AI GmbH", "countryCode": "DE" }, "tradeName": null, "deviceName": "Dental AI", "deviceModel": null, "reference": "0001", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Dental AI", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "532cb6a4358341559c8368756ee10ecf86f2d94e9a0712fd54bf056eb3b51929" }, { "id": "device-a3b8878af297e480", "title": "Diagnocat AI", "primaryDi": "00860010268001", "basicUdi": "08600102680DiagnocatAI35X", "manufacturer": { "srn": "US-MF-000035521", "name": "DGNCT LLC", "countryCode": "US" }, "tradeName": "Diagnocat AI", "deviceName": "Diagnocat AI", "deviceModel": null, "reference": "Diagnocat AI v. 3.2", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12119092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Diagnocat AI", "tier": "contextual_ai_token" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Diagnocat AI v. 3.2", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Diagnocat AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "f950156a3797a19c244062d5630d7a5a4cc2b1d64f6ef7df669cdbf41153d109" }, { "id": "device-bd6fdd1f4848f42c", "title": "Dr Jay: AI Companion", "primaryDi": "03770034957003", "basicUdi": "3770034957DRJAY4Q", "manufacturer": { "srn": "FR-MF-000042145", "name": "Dr Jay", "countryCode": "FR" }, "tradeName": "Dr Jay", "deviceName": "Dr Jay: AI Companion", "deviceModel": "Dr Jay: AI Companion", "reference": "001.0", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Dr Jay: AI Companion", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Dr Jay: AI Companion", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "780e87ce8e927f67ce199b878f47c5a41b41e79cbf34644dfc35e01aec6fc14e" }, { "id": "device-3163903c96083ed6", "title": "DR. INFO", "primaryDi": "04262582750025", "basicUdi": "426258275DRINFOFF", "manufacturer": { "srn": "DE-MF-000052647", "name": "Synduct GmbH", "countryCode": "DE" }, "tradeName": "DR. INFO AI (iOS app)", "deviceName": "DR. INFO", "deviceModel": "DR. INFO", "reference": "DRINFO-IOS", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "DR. INFO AI (iOS app)", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-08-12T00:17:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "9d4bb73ad60bd92d9dc2b9597b849645f9664449335a0785864b66d4b019984f" }, { "id": "device-8211a4ef1154411e", "title": "ECG Analysis Software", "primaryDi": "06944413814301", "basicUdi": "69444138AISEMIPV3", "manufacturer": { "srn": "CN-MF-000009957", "name": "Edan Instruments,Inc.", "countryCode": "CN" }, "tradeName": "ECG Analysis Software", "deviceName": "ECG Analysis Software", "deviceModel": null, "reference": "AI-SEMIP", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12059009", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "REFERENCE", "term": "AI", "sourceText": "AI-SEMIP", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "917521a81a6d79808a7b30c510df7f2282fa49d77b2c9f76b3dd6ba8b012cad2" }, { "id": "device-6b7fefdd4553ab4a", "title": "eMurmur Heart AI", "primaryDi": "09120087560059", "basicUdi": "912008756HEART7E", "manufacturer": { "srn": "AT-MF-000023705", "name": "CSD Labs GmbH", "countryCode": "AT" }, "tradeName": "eMurmur Heart AI", "deviceName": "eMurmur Heart AI", "deviceModel": null, "reference": "eMurmur Heart AI", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "eMurmur Heart AI", "tier": "contextual_ai_token" }, { "field": "REFERENCE", "term": "AI", "sourceText": "eMurmur Heart AI", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "eMurmur Heart AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "47ab5da7889868e49adc6cff7207dbb5bc8b639961a841a96531a824d282276d" }, { "id": "device-fdc0e2430b007764", "title": "eMurmur Lung AI", "primaryDi": "09120087560042", "basicUdi": "912008756LUNGDW", "manufacturer": { "srn": "AT-MF-000023705", "name": "CSD Labs GmbH", "countryCode": "AT" }, "tradeName": "eMurmur Lung AI", "deviceName": "eMurmur Lung AI", "deviceModel": null, "reference": "eMurmur Lung AI", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -790, "deviceStatusType": "Not intended for the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "eMurmur Lung AI", "tier": "contextual_ai_token" }, { "field": "REFERENCE", "term": "AI", "sourceText": "eMurmur Lung AI", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "eMurmur Lung AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "eef4907c5a315033baa2435d9b0d8c64077f58f469e4b31dbef1063b9aad3059" }, { "id": "device-f29849ec7d7d0a36", "title": "Fertility AI Tool", "primaryDi": "+G731FERTILITYAITOOL0C", "basicUdi": "++G731FertilityAIToolTQ", "manufacturer": { "srn": "US-MF-000046227", "name": "CERCLE.AI, INC.", "countryCode": "US" }, "tradeName": null, "deviceName": "Fertility AI Tool", "deviceModel": "Fertility AI Tool", "reference": "Fertility AI Tool", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12080282", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Fertility AI Tool", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Fertility AI Tool", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Fertility AI Tool", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "4066eeb5f18edfd90543616321a2ec63ee326119f1a6202d054a4b4880026394" }, { "id": "device-c334059d85cc6a6e", "title": "Galen AI Navigator", "primaryDi": "09309003980007", "basicUdi": "9309003980GALEN_NAVJK", "manufacturer": { "srn": "AU-MF-000052693", "name": "Indico Solutions Pty Ltd", "countryCode": "AU" }, "tradeName": "Galen AI Navigator", "deviceName": "Galen AI Navigator", "deviceModel": "Galen AI Navigator", "reference": "GALEN-NAV-v1.0.0", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Galen AI Navigator", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Galen AI Navigator", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Galen AI Navigator", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "cf238a70d3245557c054f9c1e4553bb7b2a99048b99444d62e5b8450c5237ad0" }, { "id": "device-af28937965caa7a7", "title": "Gillie.AI for Remote Monitoring", "primaryDi": "06429830117902", "basicUdi": "642983011791EC", "manufacturer": { "srn": "FI-MF-000016491", "name": "Gillie.io Company Oy", "countryCode": "FI" }, "tradeName": "Gillie.AI for Remote Monitoring", "deviceName": "Gillie.AI for Remote Monitoring", "deviceModel": null, "reference": "Gillie.AI for Remote Monitoring", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1307, "status": "Inactive", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Gillie.AI for Remote Monitoring", "tier": "contextual_ai_token" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Gillie.AI for Remote Monitoring", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Gillie.AI for Remote Monitoring", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "307c840c0e1ce49add96bd3828886d4525d8014990b0617aa511be0e77cd4968" }, { "id": "device-1663f525858bebd1", "title": "Gosta AI Operating system", "primaryDi": "06429830288503", "basicUdi": "642983028854XX20260206EH", "manufacturer": { "srn": "FI-MF-000051676", "name": "Gosta Labs Oy", "countryCode": "FI" }, "tradeName": "Gosta AI Operating system", "deviceName": "Gosta AI Operating system", "deviceModel": null, "reference": "Gosta OS", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Gosta AI Operating system", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Gosta AI Operating system", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "9833771273eea45474d34797d77004666b9b82efc97cec5c0eca51a4b16da490" }, { "id": "device-079dabdd982d3d67", "title": "Holter System", "primaryDi": "06944413829008", "basicUdi": "69444138AIHolterW5", "manufacturer": { "srn": "CN-MF-000009957", "name": "Edan Instruments,Inc.", "countryCode": "CN" }, "tradeName": "Holter System", "deviceName": "Holter System", "deviceModel": "AI Holter", "reference": "AI Holter", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12059009", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "AI Holter", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "AI Holter", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "3b955e068292813e0762bb3ee8260f27af21090a293f29d97f1fb3860b12bec0" }, { "id": "device-16acb6fbf98e5b27", "title": "inHEART Models AI", "primaryDi": "03770019599167", "basicUdi": "3770019599AIv16J", "manufacturer": { "srn": "FR-MF-000006723", "name": "inHEART", "countryCode": "FR" }, "tradeName": "inHEART Models AI", "deviceName": "inHEART Models AI", "deviceModel": null, "reference": "v3", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "inHEART Models AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "inHEART Models AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "e2001c3883cfb271a4cd820acf3534d5aef7531379074e9a34f46f466cf39975" }, { "id": "device-ce6c264246d69715", "title": "Journalia AI Scribe", "primaryDi": "07090071500007", "basicUdi": "709007150JSCRIBEFJ", "manufacturer": { "srn": "NO-MF-000051992", "name": "Journalia AS", "countryCode": "NO" }, "tradeName": "Journalia AI Scribe", "deviceName": "Journalia AI Scribe", "deviceModel": null, "reference": "JRN-AISCRIBE", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Journalia AI Scribe", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Journalia AI Scribe", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "d3246b2a051e4c2b04b0115e994e0c0cfb486dac2a0ac251716cb42dc1806eb7" }, { "id": "device-87828ba36e892691", "title": "Manual Report Generation", "primaryDi": "+G841BPAIT0031_", "basicUdi": "++G841PRAIDAIREPORTGEN6A", "manufacturer": { "srn": "PK-MF-000052649", "name": "BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED", "countryCode": "PK" }, "tradeName": "PRAID AI Report Generation Via Voice Input", "deviceName": "Manual Report Generation", "deviceModel": "BPAI-T002", "reference": "BPAI-T003", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Y211518", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "PRAID AI Report Generation Via Voice Input", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "013f6e53d891802a06e90a5aa17d0f331736580f62cb9592c2fee2a25c954f4d" }, { "id": "device-b823b65aac5c54fb", "title": "Manual Report Generation", "primaryDi": "+G841BPAIT0021.", "basicUdi": "++G841PRAIDAIREPORTGEN6A", "manufacturer": { "srn": "PK-MF-000052649", "name": "BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED", "countryCode": "PK" }, "tradeName": "PRAID AI Manual Report Generation", "deviceName": "Manual Report Generation", "deviceModel": "BPAI-T002", "reference": "PAI-T002", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Y211518", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "PRAID AI Manual Report Generation", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "c6b4ebd60700b806ecb09d7da4737c7052c424cfaff18f11efe3e4bb94dc8ad7" }, { "id": "device-d0800a8b6b7ba8ee", "title": "MDR_05_IIb_FOR_SAMD_AIRC_CT", "primaryDi": "04068151087901", "basicUdi": "0405686902380VQ", "manufacturer": { "srn": "DE-MF-000038456", "name": "Siemens Healthineers AG", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Chest CT", "deviceName": "MDR_05_IIb_FOR_SAMD_AIRC_CT", "deviceModel": "MDR_05_IIb_FOR_SAMD_AIRC_CT", "reference": "11926838", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Chest CT", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "70e033c6001208e191998990a9a7d810f169d304771a591e4842a3fce1b47b22" }, { "id": "device-c356a1377a114f42", "title": "MDR_SAMD_05_IIb_FOR_AIRC_CxR", "primaryDi": "04068151085136", "basicUdi": "0405686902373VT", "manufacturer": { "srn": "DE-MF-000038456", "name": "Siemens Healthineers AG", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Chest X-ray", "deviceName": "MDR_SAMD_05_IIb_FOR_AIRC_CxR", "deviceModel": "MDR_SAMD_05_IIb_FOR_AIRC_CxR", "reference": "11926818", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Chest X-ray", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "ca80e8b84a16f9473e7e08e210e4d976411859d4bcb90b3be558c8cd003fa5ef" }, { "id": "device-20cccf2c99ec58ee", "title": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-CV", "primaryDi": "04056869297286", "basicUdi": "0405686902145VC", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion (Cardiovascular)", "deviceName": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-CV", "deviceModel": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-CV", "reference": "11583324", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12040192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion (Cardiovascular)", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "32a7900d0b6f6419b844f113ae969d8fdbcbaf0a034a7126df9a7c67dd209d02" }, { "id": "device-e8ff78835d57e06d", "title": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-MSK", "primaryDi": "04056869297293", "basicUdi": "0405686902143V8", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion (Musculoskeletal)", "deviceName": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-MSK", "deviceModel": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-MSK", "reference": "11583325", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12040192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion (Musculoskeletal)", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "ab498a0c6247e4d830db7d19f5d3f2337d6517fdc34ead772593d0c80c46248f" }, { "id": "device-56eee62b08486710", "title": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B", "primaryDi": "04056869968278", "basicUdi": "0405686902008UZ", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Brain MR", "deviceName": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B", "deviceModel": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B", "reference": "11665399", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12040192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Brain MR", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "fe419cb70696b63f262437a6e45621552f4a0d2f10546df9061ba17ff588f375" }, { "id": "device-6ca996c8f86cda98", "title": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B", "primaryDi": "04068151033977", "basicUdi": "0405686902008UZ", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad companion Brain MR", "deviceName": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B", "deviceModel": "MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B", "reference": "11830481", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12040192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad companion Brain MR", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "b50e0e321ae2ee44491236985f473c2f00d6049a5bd44e8e39ee1efe139d6e12" }, { "id": "device-4d720daaa80439c3", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT", "primaryDi": "04068151045260", "basicUdi": "0405686902356VT", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Chest CT", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT", "reference": "11830632", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Chest CT", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "50c99aca50c015a4d82d96d6be1b4e9aa3a699b2b87475fd32ed6ccf5d15452d" }, { "id": "device-ce36ef1829d7b752", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo", "primaryDi": "04056869996172", "basicUdi": "0405686902222V5", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion (Pulmonary)", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo", "reference": "11665780", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion (Pulmonary)", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "9bd2c55a84fcef3c9b3a8215b0c042581caca01dfe1349a4f98e29d779821bfb" }, { "id": "device-29253e9f8808e512", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR", "primaryDi": "04068151009774", "basicUdi": "0405686902195VT", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Chest X-ray", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR", "reference": "11823189", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Chest X-ray", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "b09ffd9c55d8ff1c70406c275a02cd4ab85641268196a04e9c0b608d040c49d0" }, { "id": "device-b671d7feaf433424", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR", "primaryDi": "04068151046021", "basicUdi": "0405686902195VT", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Chest X-ray", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR", "reference": "11830637", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Chest X-ray", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "956f7149979dc51ed10970db29bf4422950aeb51c13f0551226b42144f707feb" }, { "id": "device-06ba5a15aac1a99e", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P", "primaryDi": "04068151000887", "basicUdi": "0405686902009V3", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Prostate MR", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P", "reference": "11666038", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Prostate MR", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "495d2618d6533642a477ced8357f33ef0952bfbca133e99b7a8b7a50f427e081" }, { "id": "device-5e743d5c8b21775f", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P", "primaryDi": "04056869298191", "basicUdi": "0405686902009V3", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Prostate MR", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P", "reference": "11582981", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Prostate MR", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "9416e1764e3a0169cea688b9bd7062cc3edb723248be01653246b949ad90f0a3" }, { "id": "device-61d7501a3cecb322", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT", "primaryDi": "04068151034189", "basicUdi": "0405686902011UN", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Organs RT", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT", "reference": "11830482", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Organs RT", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "af1b2c0db8af6123f348033eb636b4323468a90c2c5f1da0c8e18f8aa76abbe0" }, { "id": "device-a160970847412669", "title": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT", "primaryDi": "04068151010404", "basicUdi": "0405686902011UN", "manufacturer": { "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE" }, "tradeName": "AI-Rad Companion Organs RT", "deviceName": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT", "deviceModel": "MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT", "reference": "11823875", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "AI-Rad Companion Organs RT", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "a5b44bd5308e33148c39302ab2d96e8a776b8ae0e97a3ef0606b2952d13e065c" }, { "id": "device-7af66c9dd951783a", "title": "MLCL Client Software", "primaryDi": "00195278931504", "basicUdi": "8406821BUG00301GV", "manufacturer": { "srn": "US-MF-000017529", "name": "GE Medical Systems Information Technologies, Inc.", "countryCode": "US" }, "tradeName": "MLCL Client Software AltiX AI.i", "deviceName": "MLCL Client Software", "deviceModel": null, "reference": "5973597", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12050702,Z12050703", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "MLCL Client Software AltiX AI.i", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "fb35a3501f45467a6e47a90821d5b87913654ce48808dc40b12cf6c55391847d" }, { "id": "device-7a6472002e1e74a3", "title": "Noteless - AI Medical Scribe Platform", "primaryDi": "(01)05061111660007", "basicUdi": "506111166NOTELESS1403M6", "manufacturer": { "srn": "NO-MF-000052032", "name": "Noteless AS", "countryCode": "NO" }, "tradeName": null, "deviceName": "Noteless - AI Medical Scribe Platform", "deviceModel": "v2.1.14", "reference": "2.1.14", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Noteless - AI Medical Scribe Platform", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "f4e69c28ea54dd6c54b3a75e0d996a55a115d390862562cb9c9367a135ba5b6e" }, { "id": "device-29768c64d2c498c8", "title": "Omapolku", "primaryDi": "06438300000040", "basicUdi": "6438300OPU3", "manufacturer": { "srn": "FI-MF-000007401", "name": "HUS-yhtymä", "countryCode": "FI" }, "tradeName": "Omapolku Mobiili", "deviceName": "Omapolku", "deviceModel": null, "reference": "AI-00002960", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "REFERENCE", "term": "AI", "sourceText": "AI-00002960", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "7ce776a43da9d897c8791b0a61baf58ebb5b24282f354f32a982da9d3e6c458e" }, { "id": "device-7424f8151364858e", "title": "Omapolku", "primaryDi": "06438300000026", "basicUdi": "6438300OPU3", "manufacturer": { "srn": "FI-MF-000007401", "name": "HUS-yhtymä", "countryCode": "FI" }, "tradeName": "Omapolku", "deviceName": "Omapolku", "deviceModel": null, "reference": "AI-00001957", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 3, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "REFERENCE", "term": "AI", "sourceText": "AI-00001957", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "f99df6242a2cafa76535701f4e1177e36f2b75aadf70f5d40855df14188e1112" }, { "id": "device-f210b520da83d585", "title": "pcr.ai API", "primaryDi": "07290020318008", "basicUdi": "7290020318AIB4", "manufacturer": { "srn": "IL-MF-000047316", "name": "AZURE VAULT LTD", "countryCode": "IL" }, "tradeName": null, "deviceName": "pcr.ai API", "deviceModel": "PCR-AI-01", "reference": "PCR-AI-01", "medicalPurpose": null, "riskClassId": -199, "riskClass": "Class A", "legislationId": -198, "legislation": "IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)", "nomenclatureCode": "W02050192", "deviceCriterion": "STANDARD", "softwareTypeId": "-47", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": null, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "KIT": 0, "STERILE": 0, "SELF_TESTING": 0, "REAGENT": 0, "INSTRUMENT": 0, "PROFESSIONAL_TESTING": 1, "NEAR_PATIENT_TESTING": 0, "COMPANION_DIAGNOSTICS": 0 }, "evidence": [ { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "PCR-AI-01", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "PCR-AI-01", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "79a97314eb98366ec4439de5d7b99667219ccbc0aa67a1013ba8a36a129d79b0" }, { "id": "device-4655cabae13cc08b", "title": "Personal Assistant Tool", "primaryDi": "+G841BPAIT0041$", "basicUdi": "++G841PRAIDAIPERSONALASPF", "manufacturer": { "srn": "PK-MF-000052649", "name": "BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED", "countryCode": "PK" }, "tradeName": "PRAID AI Personal Assistant Tool", "deviceName": "Personal Assistant Tool", "deviceModel": "BPAI-T004", "reference": "BPAI-T004", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "TRADE_NAME", "term": "AI", "sourceText": "PRAID AI Personal Assistant Tool", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "34808aa48702e80e85cf07367633f63a774a86bfff882588f7413c60e663675a" }, { "id": "device-e3321a6b8cbb2d5d", "title": "Plan AI", "primaryDi": "05060608881574", "basicUdi": "506060888PlanAIXR", "manufacturer": { "srn": "US-MF-000020245", "name": "Sun Nuclear Corporation", "countryCode": "US" }, "tradeName": "Plan AI", "deviceName": "Plan AI", "deviceModel": "1057", "reference": "1057", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11010192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Plan AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Plan AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "89ac27ac24e459674d180e2643b60a5b6ca8d2ede7924200fdca00cc264559e4" }, { "id": "device-e6bd2fbc3405db13", "title": "PMcardio® Core AI ECG Model", "primaryDi": "04260738430135", "basicUdi": "426073843PMcardio0003H6", "manufacturer": { "srn": "SK-MF-000015799", "name": "POWERFUL MEDICAL s.r.o.", "countryCode": "SK" }, "tradeName": "PMcardio® Core AI ECG Model", "deviceName": "PMcardio® Core AI ECG Model", "deviceModel": "PMcardio® Core AI ECG Model", "reference": "Core AI ECG Model", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12050392", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 4, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "PMcardio® Core AI ECG Model", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "PMcardio® Core AI ECG Model", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Core AI ECG Model", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "PMcardio® Core AI ECG Model", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "69dce06785bf7c0a1885cde9340e2ad4a7403bd5631343928041c65d10ed13e4" }, { "id": "device-19793e8079a9e67e", "title": "PMcardio® OMI AI ECG Model", "primaryDi": "04260738430173", "basicUdi": "426073843PMcardio0002H4", "manufacturer": { "srn": "SK-MF-000015799", "name": "POWERFUL MEDICAL s.r.o.", "countryCode": "SK" }, "tradeName": "PMcardio® OMI AI ECG Model", "deviceName": "PMcardio® OMI AI ECG Model", "deviceModel": "PMcardio® OMI AI ECG Model", "reference": "OMI AI ECG Model 1.0", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12050392", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "PMcardio® OMI AI ECG Model", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "PMcardio® OMI AI ECG Model", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "OMI AI ECG Model 1.0", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "PMcardio® OMI AI ECG Model", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "2497d9002143d6fcc523f3d02b3917de0b8a4a2fe766cc6abba0da1be51414aa" }, { "id": "device-7079e74ce7e8dcd9", "title": "PMcardio® OMI AI ECG Model", "primaryDi": "04260738430081", "basicUdi": "426073843PMcardio0002H4", "manufacturer": { "srn": "SK-MF-000015799", "name": "POWERFUL MEDICAL s.r.o.", "countryCode": "SK" }, "tradeName": "PMcardio® OMI AI ECG Model", "deviceName": "PMcardio® OMI AI ECG Model", "deviceModel": "PMcardio® OMI AI ECG Model", "reference": "OMI AI ECG Model 1.0", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12050392", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 3, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "PMcardio® OMI AI ECG Model", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "PMcardio® OMI AI ECG Model", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "OMI AI ECG Model 1.0", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "PMcardio® OMI AI ECG Model", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "b01a7c7762a8b7170fbf43848122c9d3612e513dcad9b9a185564fde62bb8652" }, { "id": "device-9bb5e5c8c540d5b8", "title": "PROVEGA AI Sense", "primaryDi": "05906099119003", "basicUdi": "59060991190PAISenseVB", "manufacturer": { "srn": "PL-MF-000049936", "name": "PROVEGA IT SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ", "countryCode": "PL" }, "tradeName": "PROVEGA AI Sense", "deviceName": "PROVEGA AI Sense", "deviceModel": null, "reference": "5906099119003", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "PROVEGA AI Sense", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "PROVEGA AI Sense", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "bcbeb23184978e144d7fc8fe601195dfb960fc8e0b522c79c93782925515ec94" }, { "id": "device-212fe8dd2cfcdf3d", "title": "PYLCLARI AI", "primaryDi": "07350002338025", "basicUdi": "73500023383S", "manufacturer": { "srn": "SE-MF-000001840", "name": "EXINI Diagnostics AB", "countryCode": "SE" }, "tradeName": "PYLCLARI AI", "deviceName": "PYLCLARI AI", "deviceModel": null, "reference": "802", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z110603", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "PYLCLARI AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "PYLCLARI AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "cb01747d0d09bfa837802406c9227056f354c334d9311c79b744ab892ffa44ce" }, { "id": "device-060b6fb2ad2aa8cb", "title": "Quantib AI Node", "primaryDi": "08719689791247", "basicUdi": "8719689791QBX2PX", "manufacturer": { "srn": "NL-MF-000027601", "name": "Quantib BV", "countryCode": "NL" }, "tradeName": "Quantib AI Node 2.6", "deviceName": "Quantib AI Node", "deviceModel": "2.5", "reference": "003-260", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z119082", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Quantib AI Node", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Quantib AI Node 2.6", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "82cb244ec916f1141506b2abf082709fafa3c472297a03f211a537dc77455e1c" }, { "id": "device-378eb3bc42911f51", "title": "Quantib AI Node", "primaryDi": "08719689791285", "basicUdi": "8719689791QBX2PX", "manufacturer": { "srn": "NL-MF-000027601", "name": "Quantib BV", "countryCode": "NL" }, "tradeName": "Quantib AI Node 2.7", "deviceName": "Quantib AI Node", "deviceModel": "2.5", "reference": "003-270", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z119082", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Quantib AI Node", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Quantib AI Node 2.7", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "2c54a27abd97785e210f064dd40e530b840fde09d3e7ab24c2b2aef5048575aa" }, { "id": "device-5a38dfd44b226073", "title": "Quantib AI Node", "primaryDi": "08719689791193", "basicUdi": "8719689791QBX2PX", "manufacturer": { "srn": "NL-MF-000027601", "name": "Quantib BV", "countryCode": "NL" }, "tradeName": "Quantib AI Node", "deviceName": "Quantib AI Node", "deviceModel": "2.5", "reference": "003-250", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z119082", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Quantib AI Node", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Quantib AI Node", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "5cf3e05401c2612defe534107a559d500420efd1b09756047f16a647ea662d50" }, { "id": "device-932a927f4c0c5ec9", "title": "Quantib AI Node", "primaryDi": "08719689791308", "basicUdi": "8719689791QBX2PX", "manufacturer": { "srn": "NL-MF-000027601", "name": "Quantib BV", "countryCode": "NL" }, "tradeName": "Quantib AI Node 2.8", "deviceName": "Quantib AI Node", "deviceModel": "2.5", "reference": "003-280", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z119082", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Quantib AI Node", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Quantib AI Node 2.8", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "bb76f07006cd070b1185a737b2918e8879271ae7a225cabbf44c5c249e1cef26" }, { "id": "device-059891923778d808", "title": "Relisten AI Scribe", "primaryDi": "05391552140005", "basicUdi": "539155214RELISTEN6B", "manufacturer": { "srn": "IE-MF-000052325", "name": "Recog Analytics LTD", "countryCode": "IE" }, "tradeName": null, "deviceName": "Relisten AI Scribe", "deviceModel": null, "reference": "1", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Relisten AI Scribe", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "fe59935fa316dc721f2ece13e6a4c3255f8ed99e716cdcc6771b1ecdb0e41ded" }, { "id": "device-13fcbd636cf7965d", "title": "Retinow AI (Cloud-based software for diagnosis of retinal disorders)", "primaryDi": "08683845754011", "basicUdi": "8683845754RAI01KF", "manufacturer": { "srn": "TR-MF-000035284", "name": "Retinow Sağlık Teknolojileri ve ARGE Sanayi Anonim Şirketi", "countryCode": "TR" }, "tradeName": "Retinow", "deviceName": "Retinow AI (Cloud-based software for diagnosis of retinal disorders)", "deviceModel": "RAI01", "reference": "RAI01-V01", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12120192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Retinow AI (Cloud-based software for diagnosis of retinal disorders)", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "3bfe74a9b3530f2a62ec5d6ed0010ae24e487787960680383489759d44f9a2fd" }, { "id": "device-ab75f71543516a1d", "title": "Shen.AI", "primaryDi": "05905178315510", "basicUdi": "59051783155SHENAI_MD4P", "manufacturer": { "srn": "EE-MF-000050105", "name": "Shen.AI OÜ", "countryCode": "EE" }, "tradeName": "Shen.AI", "deviceName": "Shen.AI", "deviceModel": "Shen.AI", "reference": "SHENAI_MD", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12030292", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Shen.AI", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Shen.AI", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Shen.AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-31T00:17:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "02d5e47b85cc0407b97e2c6069b6ce9377b1f028368bc4ccad5f5391e0b5aaf7" }, { "id": "device-31d354a3137b8e61", "title": "SMARTIBD - AI software for the analysis of endoscopic video images", "primaryDi": "15065010840031", "basicUdi": "5065010840OD04PF", "manufacturer": { "srn": "GB-MF-000026653", "name": "Odin Medical Limited", "countryCode": "UK" }, "tradeName": "SMARTIBD", "deviceName": "SMARTIBD - AI software for the analysis of endoscopic video images", "deviceModel": null, "reference": "SMARTIBD", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "G99", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "SMARTIBD - AI software for the analysis of endoscopic video images", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "4d33a9d81a665f639d87b57d38a26539f5f8a4f7e20ba1c620bd86b251dc956c" }, { "id": "device-e5ec9355c756daf3", "title": "Tandem AI Medical Coder", "primaryDi": "07350179820019", "basicUdi": "735017982TANDEMCODER53", "manufacturer": { "srn": "SE-MF-000049463", "name": "Tandem Health AB", "countryCode": "SE" }, "tradeName": null, "deviceName": "Tandem AI Medical Coder", "deviceModel": null, "reference": "2", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Tandem AI Medical Coder", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "91ac52bbe6eadaf61ec317fcd264551721b73d52dae40c7ed6575bc6c7ecfa0a" }, { "id": "device-00e319e50030e9a2", "title": "Tandem AI Medical Guide", "primaryDi": "07350179820026", "basicUdi": "735017982TANDEMGUIDE7M", "manufacturer": { "srn": "SE-MF-000049463", "name": "Tandem Health AB", "countryCode": "SE" }, "tradeName": null, "deviceName": "Tandem AI Medical Guide", "deviceModel": null, "reference": "3", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Tandem AI Medical Guide", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "a4da1b65f0d788702573bf56ddcbb011cc96dd7e4a204fbfb73ac3a80d5ad4fd" }, { "id": "device-6249e57d288e5b03", "title": "Tandem AI Medical Scribe", "primaryDi": "07350179820033", "basicUdi": "735017982TANDEMSCRIBEAB", "manufacturer": { "srn": "SE-MF-000049463", "name": "Tandem Health AB", "countryCode": "SE" }, "tradeName": null, "deviceName": "Tandem AI Medical Scribe", "deviceModel": null, "reference": "1", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "V92", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Tandem AI Medical Scribe", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "d30460de5c7ae6f8d35d585f7ba6659ebf6bd99fa52ba83b4b073291a4eee69d" }, { "id": "device-af4babc936389c05", "title": "Ultrasound Image Analysis Software System", "primaryDi": "06979103230000", "basicUdi": "697910323010103010000N7", "manufacturer": { "srn": "CN-MF-000049432", "name": "Shanghai Avalantu Technology Co., Ltd.", "countryCode": "CN" }, "tradeName": "SonoPath AI", "deviceName": "Ultrasound Image Analysis Software System", "deviceModel": null, "reference": "AVL-SW-AI-TC-V1.0", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11049082", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "REFERENCE", "term": "AI", "sourceText": "AVL-SW-AI-TC-V1.0", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "SonoPath AI", "tier": "brand_only" } ], "evidenceTier": "brand_only", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "462bc7f6645b4f0914fe33ea5ade2d8ccc8aaab28171c830367427780014a011" }, { "id": "device-6b89189d9200ac2b", "title": "Vara AI", "primaryDi": "04260732180043", "basicUdi": "426073218VaraAIUJ", "manufacturer": { "srn": "DE-MF-000006986", "name": "MX Healthcare GmbH", "countryCode": "DE" }, "tradeName": "Vara AI", "deviceName": "Vara AI", "deviceModel": "1.X", "reference": "1.X", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11030292", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Vara AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Vara AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "429617da6832906ada1bebf2054e6392736a1e241dee37f358299398fa459442" }, { "id": "device-fdaf37805ba7e8e7", "title": "VUNO Med-Fundus AI", "primaryDi": "08800045800076", "basicUdi": "88000458VFSZ7", "manufacturer": { "srn": "KR-MF-000022266", "name": "VUNO Inc.", "countryCode": "KR" }, "tradeName": null, "deviceName": "VUNO Med-Fundus AI", "deviceModel": "VN-M-03", "reference": "VN-M-03", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12120192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "VUNO Med-Fundus AI", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "5880fc969ae4c1227922860359375aeaecdcb8357cb2aeb4019bcca73cb77952" }, { "id": "device-dc5303d621a5c9c4", "title": "Wounds AI", "primaryDi": "56006645657028", "basicUdi": "56006645657WDSZA", "manufacturer": { "srn": "PT-MF-000042895", "name": "F3M Information Systems S.A.", "countryCode": "PT" }, "tradeName": "Wounds AI", "deviceName": "Wounds AI", "deviceModel": "Wounds AI v1.0", "reference": "Wounds AI v1.0", "medicalPurpose": null, "riskClassId": -203, "riskClass": "Class I", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12040192", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Wounds AI", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "Wounds AI v1.0", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "Wounds AI v1.0", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Wounds AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "a26b3913aa79deb28ec5a93f3053d73de70b941ff3e050e93e4cb1cad0847f73" }, { "id": "device-19ae60f12d2c1a92", "title": "XOresearch Cardio.AI™", "primaryDi": "04751047370019", "basicUdi": "475104737CARDIOAIQE", "manufacturer": { "srn": "LV-MF-000043795", "name": "XOresearch", "countryCode": "LV" }, "tradeName": "XOresearch Cardio.AI™", "deviceName": "XOresearch Cardio.AI™", "deviceModel": "XOresearch Cardio.AI", "reference": "XOresearch Cardio.AI", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12050392", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "XOresearch Cardio.AI™", "tier": "contextual_ai_token" }, { "field": "DEVICE_MODEL", "term": "AI", "sourceText": "XOresearch Cardio.AI", "tier": "brand_only" }, { "field": "REFERENCE", "term": "AI", "sourceText": "XOresearch Cardio.AI", "tier": "brand_only" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "XOresearch Cardio.AI™", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "6498b2c52e81adc40d33975d7736e94884b91b2406301ad2edd08aec81690c4a" }, { "id": "device-7e9a5450c9998f67", "title": "ZEISS AI IOL Calculator", "primaryDi": "04049471070378", "basicUdi": "4049471_00000008_6H", "manufacturer": { "srn": "DE-MF-000007732", "name": "Carl Zeiss Meditec AG", "countryCode": "DE" }, "tradeName": "ZEISS AI IOL Calculator", "deviceName": "ZEISS AI IOL Calculator", "deviceModel": null, "reference": "7037", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12019082", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 2, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 1 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "ZEISS AI IOL Calculator", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "ZEISS AI IOL Calculator", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-24T00:17:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "3e700f9f58cc7ae0ea623932ff833725e9342d199c23dd3b14ea2ae84e2644f1" }, { "id": "device-2ebdaaffac2096ff", "title": "Zeno AI", "primaryDi": "08720299581012", "basicUdi": "63057138720299581012RJ", "manufacturer": { "srn": "NL-MF-000010947", "name": "WSK Medical", "countryCode": "NL" }, "tradeName": "Zeno AI", "deviceName": "Zeno AI", "deviceModel": "1", "reference": "1", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12149092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "aee23b3bef474192f0d1b3499399068a7a61ec3a863f4173b41ad84f3830a16f" }, { "id": "device-7a45277469195b31", "title": "Zeno AI", "primaryDi": "+G739ZENOAI0104X00L", "basicUdi": "63057138720299581012RJ", "manufacturer": { "srn": "NL-MF-000010947", "name": "WSK Medical", "countryCode": "NL" }, "tradeName": "Zeno AI", "deviceName": "Zeno AI", "deviceModel": "1", "reference": "1", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12149092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "ab3c3bf35a2144b1de932d59dff6f8ca0617890c5e38a7a6b6df1caeabb76600" }, { "id": "device-87a3109a718ee944", "title": "Zeno AI", "primaryDi": "+G739ZENOAI0102X00L", "basicUdi": "++G739ZenoAIYB", "manufacturer": { "srn": "NL-MF-000010947", "name": "WSK Medical", "countryCode": "NL" }, "tradeName": "Zeno AI", "deviceName": "Zeno AI", "deviceModel": "1", "reference": "1", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12149092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "d610d24548ed1e25100bbf4a57bcb5530cd5f8b6e57d128b58256baadab36d50" }, { "id": "device-b43863b29564dcdc", "title": "Zeno AI", "primaryDi": "+G739ZENOAI0103X00L", "basicUdi": "63057138720299581012RJ", "manufacturer": { "srn": "NL-MF-000010947", "name": "WSK Medical", "countryCode": "NL" }, "tradeName": "Zeno AI", "deviceName": "Zeno AI", "deviceModel": "1", "reference": "1", "medicalPurpose": null, "riskClassId": -205, "riskClass": "Class IIb", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z12149092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 1, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -12, "deviceStatusType": "No longer placed on the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "contextual_ai_token" }, { "field": "TRADE_NAME", "term": "AI", "sourceText": "Zeno AI", "tier": "brand_only" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-12T14:17:00.000Z", "lifecycleStatus": "observed", "removedAt": null, "sourceRecordFingerprint": "12201b7b6b45dce9f6bf8f16930982fae368d9cb71f3ddcea8797b3317a22e0c" } ], "removedDevices": [ { "id": "device-4bd2d18bd178dc66", "title": "VUNO Med-LungCT AI", "primaryDi": "08800045800083", "basicUdi": "88000458VLCYR", "manufacturer": { "srn": "KR-MF-000022266", "name": "VUNO Inc.", "countryCode": "KR" }, "tradeName": null, "deviceName": "VUNO Med-LungCT AI", "deviceModel": "VN-M-04", "reference": "VN-M-04", "medicalPurpose": null, "riskClassId": -204, "riskClass": "Class IIa", "legislationId": -197, "legislation": "MDR (REGULATION (EU) 2017/745 on medical devices)", "nomenclatureCode": "Z11069092", "deviceCriterion": "STANDARD", "softwareTypeId": "-43", "softwareType": "Software", "versionNumber": 1, "latestVersion": 1, "active": 0, "statusId": -1306, "status": "Active", "deviceStatusTypeId": -11, "deviceStatusType": "On the EU market", "substatuses": null, "flags": { "DEVICE_CRITERION": "STANDARD", "STERILE": 0, "IMPLANTABLE": 0, "MEASURING_FUNCTION": 0 }, "evidence": [ { "field": "DEVICE_NAME", "term": "AI", "sourceText": "VUNO Med-LungCT AI", "tier": "contextual_ai_token" } ], "evidenceTier": "contextual_ai_token", "firstObservedAt": "2026-07-23T11:03:00.000Z", "lastObservedAt": "2026-08-04T22:17:00.000Z", "lifecycleStatus": "removed_after_two_complete_misses", "removedAt": "2026-08-05T02:17:00.000Z", "sourceRecordFingerprint": "ae84f65b244625327bf917c39f0d541da2391bd43a1566f3c9229f0a66cf0884" } ], "manufacturers": [ { "id": "manufacturer-c1198e8391a360", "srn": "DE-MF-000006122", "name": "Siemens Healthcare GmbH", "countryCode": "DE", "deviceCount": 13, "deviceIds": [ "device-5ef2d2940b94e654", "device-20cccf2c99ec58ee", "device-e8ff78835d57e06d", "device-56eee62b08486710", "device-6ca996c8f86cda98", "device-4d720daaa80439c3", "device-ce36ef1829d7b752", "device-29253e9f8808e512", "device-b671d7feaf433424", "device-06ba5a15aac1a99e", "device-5e743d5c8b21775f", "device-61d7501a3cecb322", "device-a160970847412669" ] }, { "id": "manufacturer-59664d06d76487", "srn": "PK-MF-000052649", "name": "BAYANAAT NAHW AL MUSTAQBAL (PRIVATE) LIMITED", "countryCode": "PK", "deviceCount": 4, "deviceIds": [ "device-125048fce75128f0", "device-87828ba36e892691", "device-b823b65aac5c54fb", "device-4655cabae13cc08b" ] }, { "id": "manufacturer-f2b196b3f3ef32", "srn": "GB-MF-000026653", "name": "Odin Medical Limited", "countryCode": "UK", "deviceCount": 4, "deviceIds": [ "device-c1a343f3e8376225", "device-3dd03c3634a30ddc", "device-07b2db3a14067d57", "device-31d354a3137b8e61" ] }, { "id": "manufacturer-665b1024d63d43", "srn": "NL-MF-000027601", "name": "Quantib BV", "countryCode": "NL", "deviceCount": 4, "deviceIds": [ "device-060b6fb2ad2aa8cb", "device-378eb3bc42911f51", "device-5a38dfd44b226073", "device-932a927f4c0c5ec9" ] }, { "id": "manufacturer-937eb6d575a988", "srn": "NL-MF-000010947", "name": "WSK Medical", "countryCode": "NL", "deviceCount": 4, "deviceIds": [ "device-2ebdaaffac2096ff", "device-7a45277469195b31", "device-87a3109a718ee944", "device-b43863b29564dcdc" ] }, { "id": "manufacturer-0163c5b84e07f5", "srn": "FI-MF-000007401", "name": "HUS-yhtymä", "countryCode": "FI", "deviceCount": 3, "deviceIds": [ "device-fcf8c621a3f8c757", "device-29768c64d2c498c8", "device-7424f8151364858e" ] }, { "id": "manufacturer-a69d5c588f17c4", "srn": "SK-MF-000015799", "name": "POWERFUL MEDICAL s.r.o.", "countryCode": "SK", "deviceCount": 3, "deviceIds": [ "device-e6bd2fbc3405db13", "device-19793e8079a9e67e", "device-7079e74ce7e8dcd9" ] }, { "id": "manufacturer-8e6f8e48b585cc", "srn": "SE-MF-000049463", "name": "Tandem Health AB", "countryCode": "SE", "deviceCount": 3, "deviceIds": [ "device-e5ec9355c756daf3", "device-00e319e50030e9a2", "device-6249e57d288e5b03" ] }, { "id": "manufacturer-f501f9a7e1940e", "srn": "AT-MF-000023705", "name": "CSD Labs GmbH", "countryCode": "AT", "deviceCount": 2, "deviceIds": [ "device-6b7fefdd4553ab4a", "device-fdc0e2430b007764" ] }, { "id": "manufacturer-15f9655c16f29c", "srn": "CN-MF-000009957", "name": "Edan Instruments,Inc.", "countryCode": "CN", "deviceCount": 2, "deviceIds": [ "device-8211a4ef1154411e", "device-079dabdd982d3d67" ] }, { "id": "manufacturer-d9191416c61ad9", "srn": "JP-MF-000009291", "name": "GE Healthcare Japan Corporation", "countryCode": "JP", "deviceCount": 2, "deviceIds": [ "device-357122c81ddbcf4e", "device-eab2e88b9034882a" ] }, { "id": "manufacturer-9e93a1afc9ff1a", "srn": "US-MF-000016119", "name": "GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC", "countryCode": "US", "deviceCount": 2, "deviceIds": [ "device-20d43597a5513197", "device-c5c8a0519033dc0e" ] }, { "id": "manufacturer-1a7e4a1ade0bc7", "srn": "CN-MF-000023911", "name": "Manteia Technologies Co., Ltd.", "countryCode": "CN", "deviceCount": 2, "deviceIds": [ "device-dc75f8e9aa21f65f", "device-e062394bebb9003e" ] }, { "id": "manufacturer-81b1305347bae6", "srn": "CN-MF-000009430", "name": "Shenzhen Creative Industry Co., Ltd.", "countryCode": "CN", "deviceCount": 2, "deviceIds": [ "device-4dd543db49de1d2a", "device-c31b417ad0fb605e" ] }, { "id": "manufacturer-1bedb459c02ba1", "srn": "DE-MF-000038456", "name": "Siemens Healthineers AG", "countryCode": "DE", "deviceCount": 2, "deviceIds": [ "device-d0800a8b6b7ba8ee", "device-c356a1377a114f42" ] }, { "id": "manufacturer-4ab0fa1f395ba2", "srn": "FI-MF-000008986", "name": "Aiforia Technologies Plc", "countryCode": "FI", "deviceCount": 1, "deviceIds": [ "device-73d76258ad864932" ] }, { "id": "manufacturer-227bc7a0681853", "srn": "FR-MF-000020951", "name": "ALLISONE TECHNOLOGIES", "countryCode": "FR", "deviceCount": 1, "deviceIds": [ "device-c7038645caf73d03" ] }, { "id": "manufacturer-7a44efd76b90f5", "srn": "US-MF-000043686", "name": "Altris Inc.", "countryCode": "US", "deviceCount": 1, "deviceIds": [ "device-fea6aefe0b314626" ] }, { "id": "manufacturer-24b2224933f10b", "srn": "IL-MF-000047316", "name": "AZURE VAULT LTD", "countryCode": "IL", "deviceCount": 1, "deviceIds": [ "device-f210b520da83d585" ] }, { "id": "manufacturer-1a2d3aaa448e8d", "srn": "US-MF-000022891", "name": "Caption Health, Inc.", "countryCode": "US", "deviceCount": 1, "deviceIds": [ "device-f68123d73ee332ad" ] }, { "id": "manufacturer-e89a971173ad8c", "srn": "DE-MF-000007732", "name": "Carl Zeiss Meditec AG", "countryCode": "DE", "deviceCount": 1, "deviceIds": [ "device-7e9a5450c9998f67" ] }, { "id": "manufacturer-4d6e16f80054c2", "srn": "US-MF-000046227", "name": "CERCLE.AI, INC.", "countryCode": "US", "deviceCount": 1, "deviceIds": [ "device-f29849ec7d7d0a36" ] }, { "id": "manufacturer-6b425d6991b39e", "srn": "IN-MF-000040297", "name": "DeepTek Medical Imaging Private Limited", "countryCode": "IN", "deviceCount": 1, "deviceIds": [ "device-f03489920bff0649" ] }, { "id": "manufacturer-f9e2d80734649b", "srn": "US-MF-000035521", "name": "DGNCT LLC", "countryCode": "US", "deviceCount": 1, "deviceIds": [ "device-a3b8878af297e480" ] }, { "id": "manufacturer-ddbc3c5fe8b986", "srn": "FR-MF-000042145", "name": "Dr Jay", "countryCode": "FR", "deviceCount": 1, "deviceIds": [ "device-bd6fdd1f4848f42c" ] }, { "id": "manufacturer-c4e0b4b9c7285c", "srn": "SE-MF-000001840", "name": "EXINI Diagnostics AB", "countryCode": "SE", "deviceCount": 1, "deviceIds": [ "device-212fe8dd2cfcdf3d" ] }, { "id": "manufacturer-3bd37a65ee9b47", "srn": "PT-MF-000042895", "name": "F3M Information Systems S.A.", "countryCode": "PT", "deviceCount": 1, "deviceIds": [ "device-dc5303d621a5c9c4" ] }, { "id": "manufacturer-60dd9a45eebe65", "srn": "US-MF-000017529", "name": "GE Medical Systems Information Technologies, Inc.", "countryCode": "US", "deviceCount": 1, "deviceIds": [ "device-7af66c9dd951783a" ] }, { "id": "manufacturer-01e90a9d99a156", "srn": "FI-MF-000016491", "name": "Gillie.io Company Oy", "countryCode": "FI", "deviceCount": 1, "deviceIds": [ "device-af28937965caa7a7" ] }, { "id": "manufacturer-492792e3efe0e8", "srn": "FI-MF-000051676", "name": "Gosta Labs Oy", "countryCode": "FI", "deviceCount": 1, "deviceIds": [ "device-1663f525858bebd1" ] }, { "id": "manufacturer-be719a3a226bbb", "srn": "AU-MF-000052693", "name": "Indico Solutions Pty Ltd", "countryCode": "AU", "deviceCount": 1, "deviceIds": [ "device-c334059d85cc6a6e" ] }, { "id": "manufacturer-7341b8b1a107ef", "srn": "FR-MF-000006723", "name": "inHEART", "countryCode": "FR", "deviceCount": 1, "deviceIds": [ "device-16acb6fbf98e5b27" ] }, { "id": "manufacturer-fe33b5b2fc4438", "srn": "NO-MF-000051992", "name": "Journalia AS", "countryCode": "NO", "deviceCount": 1, "deviceIds": [ "device-ce6c264246d69715" ] }, { "id": "manufacturer-f1b4f2a2057de7", "srn": "FI-MF-000013082", "name": "MVision AI Oy", "countryCode": "FI", "deviceCount": 1, "deviceIds": [ "device-d765eaf4fa4cc222" ] }, { "id": "manufacturer-bcad662ab69a58", "srn": "DE-MF-000006986", "name": "MX Healthcare GmbH", "countryCode": "DE", "deviceCount": 1, "deviceIds": [ "device-6b89189d9200ac2b" ] }, { "id": "manufacturer-0a3f55cd11893f", "srn": "NO-MF-000052032", "name": "Noteless AS", "countryCode": "NO", "deviceCount": 1, "deviceIds": [ "device-7a6472002e1e74a3" ] }, { "id": "manufacturer-b8db4ac4e38621", "srn": "FR-MF-000002403", "name": "Olea Medical S.A.S.", "countryCode": "FR", "deviceCount": 1, "deviceIds": [ "device-2d96b3120f677558" ] }, { "id": "manufacturer-0b2d4c7a8689f2", "srn": "PL-MF-000049936", "name": "PROVEGA IT SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ", "countryCode": "PL", "deviceCount": 1, "deviceIds": [ "device-9bb5e5c8c540d5b8" ] }, { "id": "manufacturer-7eb8f0ca8ce47b", "srn": "IE-MF-000052325", "name": "Recog Analytics LTD", "countryCode": "IE", "deviceCount": 1, "deviceIds": [ "device-059891923778d808" ] }, { "id": "manufacturer-7cd40c7634f40d", "srn": "TR-MF-000035284", "name": "Retinow Sağlık Teknolojileri ve ARGE Sanayi Anonim Şirketi", "countryCode": "TR", "deviceCount": 1, "deviceIds": [ "device-13fcbd636cf7965d" ] }, { "id": "manufacturer-e31f580ec4881c", "srn": "CN-MF-000049432", "name": "Shanghai Avalantu Technology Co., Ltd.", "countryCode": "CN", "deviceCount": 1, "deviceIds": [ "device-af4babc936389c05" ] }, { "id": "manufacturer-5e125235a8008e", "srn": "EE-MF-000050105", "name": "Shen.AI OÜ", "countryCode": "EE", "deviceCount": 1, "deviceIds": [ "device-ab75f71543516a1d" ] }, { "id": "manufacturer-216b76b97e21df", "srn": "US-MF-000020245", "name": "Sun Nuclear Corporation", "countryCode": "US", "deviceCount": 1, "deviceIds": [ "device-e3321a6b8cbb2d5d" ] }, { "id": "manufacturer-ef417744565942", "srn": "DE-MF-000052647", "name": "Synduct GmbH", "countryCode": "DE", "deviceCount": 1, "deviceIds": [ "device-3163903c96083ed6" ] }, { "id": "manufacturer-30bb568419f3d7", "srn": "DE-MF-000040431", "name": "synMedico AI GmbH", "countryCode": "DE", "deviceCount": 1, "deviceIds": [ "device-da3ef73d061908e6" ] }, { "id": "manufacturer-7988f4ab238987", "srn": "KR-MF-000022266", "name": "VUNO Inc.", "countryCode": "KR", "deviceCount": 1, "deviceIds": [ "device-fdaf37805ba7e8e7" ] }, { "id": "manufacturer-0c0f55a598994a", "srn": "LV-MF-000043795", "name": "XOresearch", "countryCode": "LV", "deviceCount": 1, "deviceIds": [ "device-19ae60f12d2c1a92" ] } ], "evidenceTiers": [ { "id": "explicit", "rank": 1, "label": { "de": "expliziter KI-Begriff", "en": "explicit AI term" } }, { "id": "contextual_ai_token", "rank": 2, "label": { "de": "eigenständiges AI-Token im Kontextfeld", "en": "standalone AI token in a contextual field" } }, { "id": "brand_only", "rank": 3, "label": { "de": "AI nur im Marken-, Modell- oder Referenzfeld", "en": "AI only in a brand, model or reference field" } } ], "references": { "APPLICABLE_LEGISLATION_ID": [ { "id": "-3021", "value": "Unknown" }, { "id": "-3020", "value": "None" }, { "id": "-198", "value": "IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)" }, { "id": "-197", "value": "MDR (REGULATION (EU) 2017/745 on medical devices)" }, { "id": "-55", "value": "IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)" }, { "id": "-54", "value": "AIMDD (Directive 90/385/EEC - Active Implantable Medical Devices)" }, { "id": "-53", "value": "MDD (Directive 93/42/EEC on Medical Devices)" } ], "DEVICE_STATUS_TYPE_ID": [ { "id": "-790", "value": "Not intended for the EU market" }, { "id": "-12", "value": "No longer placed on the EU market" }, { "id": "-11", "value": "On the EU market" } ], "RISK_CLASS_ID": [ { "id": "-219", "value": "IVD devices for self-testing" }, { "id": "-205", "value": "Class IIb" }, { "id": "-204", "value": "Class IIa" }, { "id": "-203", "value": "Class I" }, { "id": "-202", "value": "Class D" }, { "id": "-201", "value": "Class C" }, { "id": "-200", "value": "Class B" }, { "id": "-199", "value": "Class A" }, { "id": "-157", "value": "IVD General" }, { "id": "-156", "value": "IVD Annex II List B" }, { "id": "-155", "value": "IVD Annex II List A" }, { "id": "-154", "value": "AIMDD" }, { "id": "-10", "value": "Class III" } ], "SPECIAL_DEVICE_TYPE_ID": [ { "id": "-3030", "value": "Made to order Rigid Gas Permeable (RGP) contact lenses" }, { "id": "-1191", "value": "Ready-made reading spectacles" }, { "id": "-1190", "value": "Spectacle lenses" }, { "id": "-1189", "value": "Spectacle frames" }, { "id": "-1188", "value": "Made to order soft contact lenses" }, { "id": "-47", "value": "Software" }, { "id": "-46", "value": "Standard Rigid Gas Permeable (RGP) Contact Lenses" }, { "id": "-44", "value": "Standard soft contact lenses" }, { "id": "-43", "value": "Software" } ], "STATUS_ID": [ { "id": "-1307", "value": "Inactive" }, { "id": "-1306", "value": "Active" } ] }, "sources": [ { "id": "eudamed-public-api", "name": "European Commission · EUDAMED Public API", "url": "https://developer.datalake.sante.service.ec.europa.eu/apis", "apiBase": "https://api.datalake.sante.service.ec.europa.eu/eudamed" }, { "id": "eudamed-overview", "name": "European Commission · EUDAMED overview", "url": "https://health.ec.europa.eu/medical-devices-eudamed/overview_en" }, { "id": "eudamed-api-guide", "name": "European Commission · Public API user guide", "url": "https://webgate.ec.europa.eu/eudamed-play-help/en/files/Public%20API%20-%20user%20guide.pdf" }, { "id": "commission-legal-notice", "name": "European Commission · Legal notice", "url": "https://commission.europa.eu/legal-notice_en" } ], "downloads": { "json": "/data/ki-medizinproduktmonitor/index.json", "devicesCsv": "/data/ki-medizinproduktmonitor/devices.csv", "evidenceCsv": "/data/ki-medizinproduktmonitor/evidence.csv", "eventsCsv": "/data/ki-medizinproduktmonitor/events.csv", "methodology": "/data/ki-medizinproduktmonitor/methodology.json" } }