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Ck Bm 100 / Bm 200

by BioMaxima Spółka Akcyjna Poland EUDAMED

Ref 1-233-0150

EMDN W01010113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439BBCH233AG Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ck Bm 100 / Bm 200
Model / Reference
1-233-0150
Primary DI / UDI-DI
05902643961784
Basic UDI-DI
59026439BBCH233AG
EMDN Code
W01010113 Creatine kinase - total
Device Class
Class B
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

Other devices from BioMaxima Spółka Akcyjna

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED ee23b64c-81f1-41bf-b155-b7ab39157f07 61 fields · synced 24 Oct 2026