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Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)

by Dirui Industrial Co., Ltd China EUDAMED

Ref 3022050Model 14 packaging specifications

EMDN W01021311

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69422022W0102131101R0LU Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
14 packaging specifications, 3022050
Primary DI / UDI-DI
06942202201868
Basic UDI-DI
69422022W0102131101R0LU
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06942202201868|69422022W0102131101R0LU 61 fields · synced 23 Oct 2026