Skip to content

Creatine Kinase MB

by Egyptian Company For Biotechnology-Spectrum Diagnostics Egypt EUDAMED

Ref 239 001

EMDN W01010114

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-62230041017624 Basic UDI-DIDate11 Mar 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 24 Oct 2026

Model / Reference
239 001
Primary DI / UDI-DI
62230041017624
Basic UDI-DI
B-62230041017624
EMDN Code
W01010114 Creatine kinase - mb activity (cc)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000032599
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Egyptian Company For Biotechnology-Spectrum Diagnostics

See all devices from Egyptian Company For Biotechnology-Spectrum Diagnostics →

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 8c66456e-299d-47ac-9693-cea96b2b1d2b 61 fields · synced 24 Oct 2026