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Apple Hearing Aid Feature
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Hearing Aid Feature 1.XModel 1.XRef Hearing Aid Feature 2.X
by Apple Inc.
Identity
- Trade Name
- Hearing Aid Feature 2.0 (HAF 2.0) FDA UDIHearing Aid Feature (HAF) FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Apple Hearing Aid Feature EUDAMEDHearing Aid Feature EUDAMEDHearing Aid Feature macOS (2.X) FDA UDIHearing Aid Feature macOS (1.X) FDA UDIHearing Aid Feature watchOS (1.X) FDA UDIHearing Aid Feature AirPods Pro 2 or later Firmware (1.X) FDA UDIHearing Aid Feature iOS (2.X) FDA UDIHearing Aid Feature iOS (1.X) FDA UDI
- Model / Reference
- 1.X EUDAMEDHearing Aid Feature 1.X EUDAMEDHearing Aid Feature 2.X EUDAMEDFeature version 2.X FDA UDIFeature version 1.X FDA UDI
- Description
- Hearing Aid Feature macOS (2.X) FDA UDIHearing Aid Feature macOS (1.X) FDA UDIHearing Aid Feature watchOS (1.X) FDA UDIHearing Aid Feature AirPods Pro 2 or later Firmware (1.X) FDA UDIHearing Aid Feature iOS (2.X) FDA UDIHearing Aid Feature iOS (1.X) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195949149931 EUDAMEDFDA UDI00195950732412 EUDAMEDFDA UDI00195950095067 EUDAMEDFDA UDI00195950095074 EUDAMEDFDA UDI00195950732382 EUDAMEDFDA UDI00195949149924 EUDAMEDFDA UDI
- Basic UDI-DI
- 0195949HAFCR EUDAMED
- Direct Marketing DI
- 00195949149931 EUDAMED00195950095067 EUDAMED00195949149924 EUDAMED00195950732382 EUDAMED00195950732412 EUDAMED00195950095074 EUDAMED
- 510(k) Number
- DEN230081 FDA UDI
- FDA Product Code
- SCR FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3335 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
Apple Hearing Aid 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 | 0195949HAFCR | 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 (12)
- EUDAMED 31dd9cd5-e866-4890-8c28-34d132f27e4c 61 fields · synced Jul 30, 2026
- FDA UDI c29bc382-89f9-40bf-bfb6-221845687cc9 34 fields · synced May 22, 2026
- FDA UDI 25754a22-511d-428c-9073-41fc915c9770 34 fields · synced May 29, 2026
- FDA UDI 31056808-d282-4621-8a85-a67f00988ec6 34 fields · synced May 29, 2026
- FDA UDI 019697b3-c0d6-4641-af51-1cd4eea3ccc0 34 fields · synced May 30, 2026
- FDA UDI 99de9095-602d-4e46-8580-8beb089bc5c5 34 fields · synced May 30, 2026
- FDA UDI 8445d022-bdc7-4360-a52e-f916dd18072c 34 fields · synced May 30, 2026
- EUDAMED 5c9640a7-8db7-475c-8d46-fbd9e40fb720 61 fields · synced Jul 9, 2026
- EUDAMED c4e36aec-a8c2-4023-9343-dd4f131551c1 61 fields · synced Jul 10, 2026
- EUDAMED 6d210eeb-f944-451f-9fbf-5da337f080c7 61 fields · synced Jul 17, 2026
- EUDAMED b9d4ecc0-03de-4a47-95f0-e1b1ca18dd4e 61 fields · synced Jul 25, 2026
- EUDAMED aaaa20f1-6fb5-43e6-84aa-10127d6e1315 61 fields · synced Jul 30, 2026