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GN Hearing 23116800

by Gn Hearing A/S

GN Hearing 23116800 is a Class II device made by Gn Hearing A/S, listed in FDA GUDID since 23 Aug 2024 (UDI-DI 05708296327225), 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 Number05708296327225 UDI-DI Date23 Aug 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  • Withdrawn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
GN Hearing
Generic name
Audiometric/hearing device software
Model / reference
23116800
Primary DI / UDI-DI
05708296327225
FDA product code
OSM
GMDN term
Audiometric/hearing device software
Device class
Class II
Regulation number
874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Audiometric/hearing device software

Similar devices

Other devices filed under FDA product code OSM (Hearing Aid, Air-Conduction with Wireless Technology, Prescription).

Other devices from Gn Hearing A/S

See all devices from Gn Hearing A/S →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)