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Widex UNIQUE U-FA 100

by Widex A/S 14 variants

Widex UNIQUE U-FA 100 (10975432) is a Class II device made by Widex A/S, listed in FDA GUDID since 17 Mar 2024 (UDI-DI 05706069698077), 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 Number05706069698077 UDI-DI Date17 Mar 2024ListedStatusListed 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  • Withdrawn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
Widex
Generic name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
UNIQUE U-FA 100, 10975432
Primary DI / UDI-DI
05706069698077
FDA product code
OSM
GMDN term
Air-conduction hearing aid, behind-the-ear
Device class
Class II
Regulation number
874.3305
GUDID distribution status
In Commercial Distribution

Related devices

Category: Air-conduction hearing aid, behind-the-ear

Other devices from Widex A/S

See all devices from Widex A/S →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)