Identity
- Trade Name
- audifon FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- BTE-TRT FDA UDI
- Model / Reference
- miro P TRT FDA UDI
- Description
- BTE-TRT FDA UDI
Identifiers
- Catalog Number
- 021702-8283-313-1720 FDA UDI
- Primary DI / UDI-DI
- EADF021702828331317201 FDA UDI
- 510(k) Number
- K130514 FDA UDI
- FDA Product Code
- KLW FDA UDIESD FDA UDI
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3300 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
audifon by audifon GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
Sources (1)
- FDA UDI d3faa7ec-9ddd-418f-a45d-da7390eba926 36 fields · synced Jun 9, 2026