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Creatine Kinase Mb (Ck-Mb)- (4+1)

by Spectrum for Diagnostic Industries (Joint Stock Company) EUDAMED

Active European Union

Ref 167 05 005

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-G45816705005AP Basic UDI-DIDate5 Aug 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  • Withdrawn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

Device Name
Creatine Kinase Mb (Ck-Mb)
Model / Reference
167 05 005
Primary DI / UDI-DI
G45816705005AP
Basic UDI-DI
B-G45816705005AP
EMDN Code
W01010114 Creatine kinase - mb activity (cc)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000033954
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Spectrum for Diagnostic Industries (Joint Stock Company)

See all devices from Spectrum for Diagnostic Industries (Joint Stock Company) →

Properties

  • 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