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Hc-Ck-Mb

by PZ CORMAY Spółka Akcyjna Poland EUDAMED

Ref 4-527Model HC-CK-MB

EMDN W01010114

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514645275 Basic UDI-DIDate18 Jul 2025RegisteredStatusActive

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 22 Oct 2026

Device Name
Ck-Mb
Model / Reference
HC-CK-MB, 4-527
Primary DI / UDI-DI
05907514645275
Basic UDI-DI
B-05907514645275
EMDN Code
W01010114 Creatine kinase - mb activity (cc)
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

Other devices from PZ CORMAY Spółka Akcyjna

See all devices from PZ CORMAY Spółka Akcyjna →

Properties & raw data

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

Sources (1)

  • EUDAMED 49c8f6f7-3efc-4ef8-8d36-7582dbbc9b2f 61 fields · synced 22 Oct 2026