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Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）

by Dirui Industrial Co., Ltd EUDAMED

Active European Union

Ref 3021639Model R1: 4x50mL, R2: 2x25mL， Calibration sample: 1x1mL, Control: 2x1mL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06925794592637 Basic UDI-DIDate13 May 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  • Withdrawn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
R1: 4x50mL, R2: 2x25mL， Calibration sample: 1x1mL, Control: 2x1mL, 3021639
Primary DI / UDI-DI
06925794592637
Basic UDI-DI
B-06925794592637
EMDN Code
W01010115 Creatine kinase isoenzymes
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

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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