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INNOVIQURE D-dimer Reagent Kit

by Deni̇z Bi̇yoki̇mya Ürünleri̇ Diş Ti̇c. A.Ş. Gazi̇emi̇r İzmi̇r Şubesi̇ 3 variants

Ref 704253Model 100T

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-8683981704253F7 Basic UDI-DI D-8683981704253F7UDI-DIDate8 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
100T, 704253
Primary DI / UDI-DI
D-8683981704253F7
Basic UDI-DI
B-8683981704253F7
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000034179

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No