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SIGNIA Remote Control

by WS Audiology USA, Inc.

Ref 21052417Model REMOTE

SIGNIA Remote Control (21052417) is a device classified as Class I in the EU and Class II in the US made by WS Audiology USA, Inc., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 5714880-WSA-99-60-87) and listed in FDA GUDID since 21 Aug 2026 (UDI-DI 05714880297461), 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 Number5714880-WSA-99-60-87 Basic UDI-DI 05714880297461UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05714880297461 UDI-DI Date21 Aug 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5714880-WSA-99-60-87 registered 21 Aug 2026 Active
  • FDA GUDID UDI-DI 05714880297461 listed 21 Aug 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 5714880-WSA-99-60-87
  2. Listed FDA GUDID 05714880297461

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  • Withdrawn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
Set Signia Remote Control EUDAMED
Signia GUDID
Generic name
Hearing aid/implant system remote control
Model / Ref / Catalog
REMOTE, 21052417, Remote Control
Primary DI / UDI-DI
05714880297461
Basic UDI-DI
5714880-WSA-99-60-87
FDA product code
OSM
EMDN code
Y214580 Hearing aids or hearing devices - accessories
GMDN term
Hearing aid/implant system remote control
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.3305
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REMOTE
21052417
GUDID
Remote Control
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.

Similar devices in this category

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

Other devices from WS Audiology USA, Inc.

See all devices from WS Audiology USA, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)