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Bernafon 191305

by Bernafon, Inc.

Bernafon 191305 is a Class II device made by Bernafon, Inc., listed in FDA GUDID since 20 Aug 2018 (UDI-DI 05711584086179), 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 Number05711584086179 UDI-DI Date20 Aug 2018ListedStatusListed 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  • Withdrawn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
Air-conduction hearing aid, receiver-in-the-ear
Model / reference
191305
Primary DI / UDI-DI
05711584086179
FDA product code
KLW, OSM
GMDN term
Air-conduction hearing aid, receiver-in-the-ear
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, receiver-in-the-ear

Similar devices in this category

Other devices from Bernafon, Inc.

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)