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Bernafon 190112

by Bernafon, Inc.

Bernafon 190112 is a Class II device made by Bernafon, Inc., listed in FDA GUDID since 20 Aug 2018 (UDI-DI 05711584090220), 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 Number05711584090220 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  • Withdrawn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
Hearing aid wireless-fitting computer-aided set
Model / reference
190112
Primary DI / UDI-DI
05711584090220
FDA product code
KLW, OSM
GMDN term
Hearing aid wireless-fitting computer-aided set
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Hearing aid wireless-fitting computer-aided set

Similar devices

Other devices filed under FDA product code KLW (Masker, tinnitus).

Other devices from Bernafon, Inc.

See all devices from Bernafon, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)