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Creatine Kinase Reagent Kit(ifcc Method)

by Dirui Industrial Co., Ltd China EUDAMED

Ref 232012902010Model R1: 2x60mL, R2: 2x15mL

EMDN W01010113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942202260711 Basic UDI-DIDate23 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
R1: 2x60mL, R2: 2x15mL, 232012902010
Primary DI / UDI-DI
06942202260711
Basic UDI-DI
B-06942202260711
EMDN Code
W01010113 Creatine kinase - total
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

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

Other devices from Dirui Industrial Co., Ltd

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Properties & raw data

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

Sources (1)

  • EUDAMED eadf54a0-7cd2-4eb4-8d12-33f95b4f86eb 61 fields · synced 25 Oct 2026