Identity
- Trade Name
- Hearing Test Feature (HTF) FDA UDI
- Generic Name
- Self-testing tone audiometer FDA UDI
- Device Name
- Hearing Test Feature iOS (1.X) FDA UDI
- Model / Reference
- Feature version 1.X FDA UDI
- Description
- Hearing Test Feature iOS (1.X) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195949149948 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Self-testing tone audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Self-testing tone audiometer
Hearing Test Feature (HTF) by Apple Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Self-testing tone audiometer.
- Jacoti Hearing Center — Jacoti · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Apple Inc.
Sources (2)
- FDA UDI 3d1f8168-830e-41d3-a932-9ab68ef06bc4 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026