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Irregular Rhythm Notification Feature
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1.X
by Apple Inc.
Identity
- Trade Name
- Irregular Rhythm Notifications FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Irregular Rhythm Notification Feature EUDAMED
- Model / Reference
- 1.X EUDAMEDFeature Version 1.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190198909527 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190198IRNFeature3T EUDAMED
- Direct Marketing DI
- 00190198909527 EUDAMED
- 510(k) Number
- DEN180042 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0190198IRNFeature3T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Apple Inc.
- EUDAMED SRN
- US-MF-000013709
- Authorised Representative
- Apple Distribution International Limited IE-AR-000012406
Sources (2)
- EUDAMED 6b89239b-8420-4180-a3de-35919fa51f83 61 fields · synced Jul 15, 2026
- FDA UDI c47ec2ce-a97a-4f93-8cdc-bf09f9f015f4 33 fields · synced May 29, 2026