Skip to content

INNOVIQURE CK-MB Reagent Kit

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

Active European Union

Ref 703294Model 400T

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-8683981703294FE Basic UDI-DIDate5 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
400T, 703294
Primary DI / UDI-DI
D-8683981703294FE
Basic UDI-DI
B-8683981703294FE
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000034179

Other devices from Deni̇z Bi̇yoki̇mya Ürünleri̇ Diş Ti̇c. A.Ş. Gazi̇emi̇r İzmi̇r Şubesi̇

See all devices from Deni̇z Bi̇yoki̇mya Ürünleri̇ Diş Ti̇c. A.Ş. Gazi̇emi̇r İzmi̇r Şubesi̇ →

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