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Ck

by Instrumentation Laboratory SpA Italy EUDAMED

Ref 0018164640

EMDN W01010113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84269513940508Y Basic UDI-DIDate4 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
0018164640
Primary DI / UDI-DI
08426951394050
Basic UDI-DI
84269513940508Y
Direct Marketing DI
08426951394050
EMDN Code
W01010113 Creatine kinase - total
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009277

Other devices from Instrumentation Laboratory SpA

See all devices from Instrumentation Laboratory SpA →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED c6eefcf6-aac4-46bc-9c7e-a125c95b34bd 61 fields · synced 22 Oct 2026