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CK-MM HumaFIA SR

by Beijing HumaDX Tech Co., Ltd. EUDAMED

Active European Union

Ref 16090/335Model 25T

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976343800970 Basic UDI-DIDate11 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
CK-MM HumaFIA SR
Model / Reference
25T, 16090/335
Primary DI / UDI-DI
06976343800970
Basic UDI-DI
B-06976343800970
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000029051
Authorised representative
Human Gesellschaft für Biochemica und Diagnostica mbH DE-AR-000025586

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Properties

  • 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