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Bernafon 205976

by Bernafon, Inc.

Bernafon 205976 is a Class II device made by Bernafon, Inc., listed in FDA GUDID since 22 Aug 2019 (UDI-DI 05711584109359), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05711584109359 UDI-DI Date22 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Bernafon
Generic name
Hearing aid wireless-fitting computer-aided set
Model / reference
205976
Primary DI / UDI-DI
05711584109359
FDA product code
OSM, KLW
GMDN term
Hearing aid wireless-fitting computer-aided set
Device class
Class II
Regulation number
874.3305, 874.3400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)