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SIGNIA KIT Silk C&G sDemo DIX RB

by WS Audiology USA, Inc.

Ref 21055070Model INSTANT FIT

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05714880296648 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5714880-WSA-28-30-4J Basic UDI-DI 05714880296648UDI-DIDate11 Jul 2025RegisteredStatusActive

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  • Withdrawn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
Kit Silk C&G Sd IX Rb Blk Tr EUDAMED
Signia GUDID
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
INSTANT FIT, 21055070, KIT Silk C&G sDemo DIX RB
Primary DI / UDI-DI
05714880296648
Basic UDI-DI
5714880-WSA-28-30-4J
FDA Product Code
OSM, KLW
EMDN Code
Y2145060201 Hearing aid in the-ear (ite)
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305, 874.3400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
INSTANT FIT
21055070
GUDID
KIT Silk C&G sDemo DIX RB
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • 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
  • Manufacturing Date: No