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Hearing Aid Feature (2.X)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2.XModel 1.X
by Apple Inc.
Identity
- Trade Name
- Hearing Aid Feature (2.X) EUDAMEDHearing Aid Feature 2.0 (HAF 2.0) FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Apple Hearing Aid Feature EUDAMEDHearing Aid Feature AirPods Pro 2 or later Firmware (2.X) FDA UDI
- Model / Reference
- 1.X EUDAMED2.X EUDAMEDFeature version 2.X FDA UDI
- Description
- Hearing Aid Feature AirPods Pro 2 or later Firmware (2.X) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195950732405 EUDAMEDFDA UDI
- Basic UDI-DI
- 0195949HAFCR EUDAMED
- Direct Marketing DI
- 00195950732405 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 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
Hearing Aid Feature (2.X) 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 (2)
- EUDAMED de5b81a1-9ec7-4a2f-9aa5-41275fa93ea6 61 fields · synced Jun 17, 2026
- FDA UDI fa75931b-52dc-49f7-aea9-403f6502d67e 34 fields · synced May 30, 2026