← Back to catalogue
Hypertension Notification Feature
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1.XRef Hypertension Notification Feature 1.X
by Apple Inc.
Identity
- Trade Name
- Hypertension Notification Feature (HTNF) FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Hypertension Notification Feature EUDAMEDHypertension Notification Feature iOS (HTNF) FDA UDIHypertension Notification Feature watchOS (HTNF) FDA UDI
- Model / Reference
- 1.X EUDAMEDHypertension Notification Feature 1.X EUDAMEDFeature version 1.X FDA UDI
- Description
- Hypertension Notification Feature iOS (HTNF) FDA UDIHypertension Notification Feature watchOS (HTNF) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195949001796 EUDAMEDFDA UDI00195949001789 EUDAMEDFDA UDI
- Basic UDI-DI
- 0195949HTNF2 EUDAMED
- Direct Marketing DI
- 00195949001796 EUDAMED00195949001789 EUDAMED
- 510(k) Number
- K250507 FDA UDI
- FDA Product Code
- SFR 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
- 870.2380 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMEDIreland 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
Hypertension 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 | 0195949HTNF2 | 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 (5)
- EUDAMED c554c5fd-1a69-43a1-8dff-065eb2e9cd77 61 fields · synced Aug 1, 2026
- FDA UDI 9cebb6df-eada-4ffb-bc31-05bd8a2f480d 34 fields · synced May 29, 2026
- FDA UDI 9d1c233b-bc33-48ff-b0fd-eb1b5761da70 34 fields · synced May 30, 2026
- EUDAMED 764dda04-bdd4-4ff9-a40a-4ea38e811244 61 fields · synced Jul 10, 2026
- EUDAMED 9703cfd5-1f53-4a6a-9bbd-b7ef28fed3ee 61 fields · synced Aug 1, 2026