Identity
- Trade Name
- Bernafon FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- ZR5, KIT 10 NFM 75 BE ZERENA 5 FDA UDI
- Model / Reference
- 186044 FDA UDI
- Description
- ZR5, KIT 10 NFM 75 BE ZERENA 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05711584083581 FDA UDI
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3305 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, in-the-ear
Bernafon by Bernafon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, in-the-ear.
- AUDIBEL — Starkey Laboratories Inc. · Class II
- Unitron — Unitron Hearing · Class I
- AGX — Widex A/S · Class II
- Widex — Widex A/S · Class II
- Ceretone — AUDICON CORPORATION · Class I
- AUDIGY — Starkey Laboratories Inc. · Class II
- Widex — Widex A/S · Class II
- GN ReSound — Gn Hearing 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 3a61c17a-3fbd-4dfe-92e0-8ffdc2f945d9 34 fields · synced Jun 6, 2026