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S_ite If Cic Li D 8SR Blk Trd

by Wsaud a/S

Ref 21035034Model 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05714880219951 UDI-DI Date28 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5714880-WSA-28-30-4J Basic UDI-DI 05714880219951UDI-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  • Withdrawn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
S_ite If Cic Li D 8SR Blk Trd EUDAMED
Audio Service GUDID
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
INSTANT FIT, 21035034, IF CIC Li D 8
Primary DI / UDI-DI
05714880219951
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
21035034
GUDID
IF CIC Li D 8
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000015974

Other devices from Wsaud a/S

See all devices from Wsaud a/S →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No