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Ha Ejy E-Fm E22 E220 Sgld

by Widex A/S

Ref 10989793Model BTE

Ha Ejy E-Fm E22 E220 Sgld (10989793) is an air-conduction hearing aid (EU MDD Class IIa; FDA Class II) made by Widex A/S, registered in EUDAMED on 17 Jul 2025 (Basic UDI-DI B-05706069839319) and listed in FDA GUDID since 24 Jan 2024 (UDI-DI 05706069839319), active as of 22 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-05706069839319 Basic UDI-DI 05706069839319UDI-DIDate17 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05706069839319 UDI-DI Date24 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05706069839319 registered 17 Jul 2025 Active
  • FDA GUDID UDI-DI 05706069839319 listed 24 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05706069839319
  2. Registered EUDAMED B-05706069839319

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ha Ejy E-Fm E22 E220 Sgld EUDAMED
Widex GUDID
Generic name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
BTE, 10989793, ENJOY E-FM 220
Primary DI / UDI-DI
05706069839319
Basic UDI-DI
B-05706069839319
FDA product code
OSM, KLW
EMDN code
Y2145060101 Behind-the-ear hearing aids with receiver in the device (bte)
GMDN term
Air-conduction hearing aid, behind-the-ear
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.3305, 874.3400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BTE
10989793
GUDID
ENJOY E-FM 220
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.

Manufacturer details

EUDAMED SRN
DK-MF-000025153

Related devices

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

Similar devices in this category

Other devices filed under BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE).

Other devices from Widex A/S

See all devices from Widex A/S →

Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)