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GN Hearing 21591400

by Gn Hearing A/S

Ref 21591400Model Dome

GN Hearing 21591400 is an earmould (EU MDR Class IIa; FDA Class II; FDA product code OSM, Hearing aid, air conduction with wireless technology) made by Gn Hearing A/S, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 57082960000423B) and listed in FDA GUDID since 7 Aug 2020 (UDI-DI 05708296209521), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57082960000423B Basic UDI-DI 05708296209521UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708296209521 UDI-DI Date7 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57082960000423B registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 05708296209521 listed 7 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05708296209521
  2. Registered EUDAMED 57082960000423B

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  • Withdrawn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
Earmould, preformed
Model / reference
21591400, Dome
Primary DI / UDI-DI
05708296209521
Basic UDI-DI
57082960000423B
FDA product code
OSM
EMDN code
Y214580 Hearing aids or hearing devices - accessories
GMDN term
Earmould, preformed
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.3305
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Earmould, preformed

Similar devices in this category

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

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 (22, all answered No)