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Creatine Kinase (CK)

by Spectrum for Diagnostic Industries (Joint Stock Company) Egypt EUDAMED

Ref 238 002 EMDN W01010113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-G4582380028M Basic UDI-DIDate5 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
238 002
Primary DI / UDI-DI
G4582380028M
Basic UDI-DI
B-G4582380028M
EMDN Code
W01010113 Creatine kinase - total
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 & 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 G4582380028M|B-G4582380028M 61 fields · synced 25 Oct 2026