Bernafon 185290
Bernafon 185290 is a Class II device made by Bernafon, Inc., listed in FDA GUDID since 30 Nov 2017 (UDI-DI 05711584082812), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05711584082812 | Date30 Nov 2017 | StatusListed |
Official records
- AccessGUDID record 05711584082812
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Bernafon
- Generic name
- Audiometric/hearing device software
- Model / reference
- 185290
- Primary DI / UDI-DI
- 05711584082812
- FDA product code
- OSM, KLW
- GMDN term
- Audiometric/hearing device software
- Device class
- Class II
- Regulation number
- 874.3305, 874.3400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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