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Irregular Rhythm Notification Feature
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2.X
by Apple Inc.
Identity
- Trade Name
- Irregular Rhythm Notification feature 2.0 FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Irregular Rhythm Notification Feature EUDAMEDIrregular Rhythm Notification feature iPhone App (Version 2.0) FDA UDI
- Model / Reference
- 2.X EUDAMEDFeature Version 2.x FDA UDI
- Description
- Irregular Rhythm Notification feature iPhone App (Version 2.0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194252456781 EUDAMEDFDA UDI
- Basic UDI-DI
- 0194252IRNFeature22Q EUDAMED
- Direct Marketing DI
- 00194252456781 EUDAMED
- 510(k) Number
- K212516 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
- Germany 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
Irregular Rhythm Notification 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 | DEN180042 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0194252IRNFeature22Q | 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 (3)
- EUDAMED 8628c1af-0c8e-451c-8ea4-a3042c7c0051 61 fields · synced Jul 23, 2026
- FDA UDI fe8f35cc-4f0c-416d-b9a8-f7cf92bdcf44 34 fields · synced May 30, 2026
- FDA 510(k) DEN180042 1 fields · synced May 18, 2026