Identity
- Trade Name
- Bernafon FDA UDI
- Generic Name
- Hearing aid wireless-fitting computer-aided set FDA UDI
- Device Name
- CAPTO 5 B 105 FW 2.0 FDA UDI
- Model / Reference
- 187292 FDA UDI
- Description
- CAPTO 5 B 105 FW 2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05711584084885 FDA UDI
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- GMDN Term
- Hearing aid wireless-fitting computer-aided set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Hearing aid wireless-fitting computer-aided set
Bernafon by Bernafon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid wireless-fitting computer-aided set.
- Philips — Sbo Hearing A/S · Class II
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- HHM — Sbo Hearing A/S · Class II
- Oticon — Sbo Hearing A/S · Class II
- Maico — Sbo Hearing A/S · Class II
- Oticon — Sbo Hearing A/S · Class II
- Maico — Sbo Hearing A/S · Class II
- Oticon — Oticon A/S · Class II
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
- Bernafon, Inc.
Sources (1)
- FDA UDI 6df7c71e-aea3-410e-b855-10b199b74c7e 34 fields · synced Jun 8, 2026