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23849700

by GN Hearing A/S

Ref 23849700Model Multi Mic

23849700 is a device classified as Class I in the EU and Class II in the US made by Gn Hearing A/S, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 57082960000393N) and listed in FDA GUDID since 21 Oct 2026 (UDI-DI 05708296447022), active as of 2 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05708296447022 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number57082960000393N Basic UDI-DI 05708296447022UDI-DIDate29 Sep 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57082960000393N registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 05708296447022 listed 21 Oct 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 57082960000393N
  2. Listed FDA GUDID 05708296447022

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
GN Hearing
Generic name
Hearing aid enhanced audio device, telecommunication/multimedia
Model / reference
Multi Mic, 23849700
Primary DI / UDI-DI
05708296447022
Basic UDI-DI
57082960000393N
FDA product code
OSM
EMDN code
Y214580 Hearing aids or hearing devices - accessories
GMDN term
Hearing aid enhanced audio device, telecommunication/multimedia
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.3305
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DK-MF-000009536

Similar devices in this category

Other devices filed under HEARING AIDS OR HEARING DEVICES - ACCESSORIES.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)