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Acc. Com-Dex (Sb) Cmwht

by Wsaud a/S

Ref 8 925 0101 109Model STREAMER

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5714880-WSA-63-54-55 Basic UDI-DI 05706069580938UDI-DIDate9 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05706069580938 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Acc. Com-Dex (Sb) Cmwht EUDAMED
Widex GUDID
Generic Name
Hearing aid enhanced audio device, telecommunication/multimedia
Model / Ref / Catalog
STREAMER, 8 925 0101 109, COM-DEX
Primary DI / UDI-DI
05706069580938
Basic UDI-DI
5714880-WSA-63-54-55
FDA Product Code
ESD
EMDN Code
Y214580 Hearing aids or hearing devices - accessories
GMDN Term
Hearing aid enhanced audio device, telecommunication/multimedia
Device Class
Class I
Regulation Number
874.3300
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
STREAMER
8 925 0101 109
GUDID
COM-DEX

Manufacturer details

EUDAMED SRN
DK-MF-000015974

Other devices from Wsaud a/S

See all devices from Wsaud a/S →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No