← Back to catalogue
Sleep Apnea Notification Feature
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Sleep Apnea Notification Feature 1.X
by Apple Inc.
Identity
- Trade Name
- Sleep Apnea Notification Feature (SANF) FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Sleep Apnea Notification Feature EUDAMEDSleep Apnea Notification Feature iOS (version 1.X) FDA UDI
- Model / Reference
- Sleep Apnea Notification Feature 1.X EUDAMEDFeature version 1.X FDA UDI
- Description
- Sleep Apnea Notification Feature iOS (version 1.X) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195949116209 EUDAMEDFDA UDI
- Basic UDI-DI
- 0195949SANF55 EUDAMED
- Direct Marketing DI
- 00195949116209 EUDAMED
- 510(k) Number
- K240929 FDA UDI
- FDA Product Code
- QZW 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
- 868.2378 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
No
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
Sleep Apnea 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 | 0195949SANF55 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apple Inc.
- EUDAMED SRN
- US-MF-000013709
- Authorised Representative
- Apple Distribution International Limited IE-AR-000012406
Sources (2)
- EUDAMED 87b27676-121d-4311-807d-48f42131e408 61 fields · synced Jul 31, 2026
- FDA UDI e891b120-d4a1-414e-bf22-fd88e2c95644 34 fields · synced May 30, 2026