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Apple Hearing Test Feature
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Hearing Test Feature 1.XModel 1.X
by Apple Inc.
Identity
- Trade Name
- Hearing Test Feature (HTF) FDA UDI
- Generic Name
- Self-testing tone audiometer FDA UDI
- Device Name
- Apple Hearing Test Feature EUDAMEDHearing Test Feature AirPods Pro 2 Firmware (1.X) FDA UDI
- Model / Reference
- 1.X EUDAMEDHearing Test Feature 1.X EUDAMEDFeature version 1.X FDA UDI
- Description
- Hearing Test Feature AirPods Pro 2 Firmware (1.X) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195949149955 EUDAMEDFDA UDI
- Basic UDI-DI
- 0195949HTTV EUDAMED
- Direct Marketing DI
- 00195949149955 EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z12149092 VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Self-testing tone audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 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
Yes
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 Test 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 | 0195949HTTV | 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 419e4f4d-483a-4f3f-a5d9-c1ac46c6d8e5 61 fields · synced Jun 8, 2026
- FDA UDI d1803bbe-7981-4d99-bf95-cfadf08bcf10 33 fields · synced May 29, 2026