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Ck-Mb

by Vitro Scient EUDAMED

Withdrawn No longer placed on the EU market

Ref 11405Model 6 X 10 ml - 11405

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-+G437114050 Basic UDI-DIDate6 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
6 X 10 ml - 11405, 11405
Primary DI / UDI-DI
+G437114050
Basic UDI-DI
B-+G437114050
EMDN Code
W01010114 Creatine kinase - mb activity (cc)
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
EG-MF-000053361
Authorised representative
MDSS GmbH DE-AR-000005430

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