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GN Hearing 22020108

by Gn Hearing A/S

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05708296227228 UDI-DI Date11 Jun 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GN Hearing
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Reference
22020108
Primary DI / UDI-DI
05708296227228
FDA Product Code
OSM, KLW
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class II
Regulation Number
874.3305, 874.3400
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

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

Other devices from Gn Hearing A/S

See all devices from Gn Hearing A/S →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: 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