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Widex D-9

by Widex A/S 28 variants

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05706069487015 UDI-DI Date1 Sep 2016ListedStatusListed 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  • Withdrawn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
D-9, 8 342 0101 081
Primary DI / UDI-DI
05706069487015
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
MRI safety
MR Conditional

Related devices

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

Other devices from Widex A/S

See all devices from Widex A/S →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Expiration date: No