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Atrial Fibrillation History Feature
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Atrial Fibrillation History Feature V1.XRef Atrial Fibrillation History Feature 1.X
by Apple Inc.
Identity
- Trade Name
- Atrial Fibrillation History Feature FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Atrial Fibrillation History Feature EUDAMEDAtrial Fibrillation History Feature iPhone app FDA UDIAtrial Fibrillation History Feature Watch app FDA UDI
- Model / Reference
- Atrial Fibrillation History Feature V1.X EUDAMEDAtrial Fibrillation History Feature 1.X EUDAMEDFeature version 1.x FDA UDI
- Description
- Atrial Fibrillation History Feature iPhone app FDA UDIAtrial Fibrillation History Feature Watch app FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194252456804 EUDAMEDFDA UDI00194252456798 EUDAMEDFDA UDI
- Basic UDI-DI
- 0194252AFHFeatureCH EUDAMED
- Direct Marketing DI
- 00194252456804 EUDAMED00194252456798 EUDAMED
- 510(k) Number
- K213971 FDA UDI
- FDA Product Code
- QDB FDA UDI
- EMDN Code
- Z12039092 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2790 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Atrial Fibrillation History Feature by Apple Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213971 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0194252AFHFeatureCH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apple Inc.
- EUDAMED SRN
- US-MF-000013709
- Authorised Representative
- Apple Distribution International Limited IE-AR-000012406
Sources (5)
- EUDAMED 53d05adb-6b74-433e-be06-de01574fbe79 61 fields · synced Sep 18, 2026
- FDA UDI 3e305f88-fe98-478b-a50b-393a358f46af 34 fields · synced May 29, 2026
- FDA UDI 7f87bee0-7ad3-4e74-a832-1f0dca0b66f5 34 fields · synced May 30, 2026
- EUDAMED ca1ab1c2-2132-4722-ac8f-431c0d4af9d0 61 fields · synced Jul 23, 2026
- FDA 510(k) K213971 1 fields · synced May 18, 2026