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GN Hearing 21384100

by Gn Hearing A/S

Ref 21384100Model TMRIE

GN Hearing 21384100 is a device classified as Class IIa in the EU and Class I in the US made by Gn Hearing A/S, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 57082960000443F) and listed in FDA GUDID since 8 May 2024 (UDI-DI 05708296219292), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57082960000443F Basic UDI-DI 05708296219292UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708296219292 UDI-DI Date8 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57082960000443F registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 05708296219292 listed 8 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05708296219292
  2. Registered EUDAMED 57082960000443F

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  • Withdrawn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
Air-conduction hearing aid, receiver-in-canal
Model / reference
21384100, TMRIE
Primary DI / UDI-DI
05708296219292
Basic UDI-DI
57082960000443F
FDA product code
ESD
EMDN code
Y214580 Hearing aids or hearing devices - accessories
GMDN term
Air-conduction hearing aid, receiver-in-canal
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.3300
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 I

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

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

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