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Ck

by Medicon Hellas SA Greece EUDAMED

Ref 1415-0090

EMDN W01010113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5204309000014NM Basic UDI-DIDate22 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
1415-0090
Primary DI / UDI-DI
05204309167272
Basic UDI-DI
5204309000014NM
EMDN Code
W01010113 Creatine kinase - total
Device Class
Class C
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000013625

Other devices from Medicon Hellas SA

See all devices from Medicon Hellas SA →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 0ff8abea-9d9f-4182-9592-c1e429a9c379 61 fields · synced 24 Oct 2026