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Creatine kinase MB(CK-MB) Determination Kit(Chemiluminescence Immunoassay)

by Shenzhen Channel Biotechnology Co., Ltd.

Ref CR026EU01Model 10 Tests/Kit or 20 Tests/Kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968300749 Basic UDI-DI 06976968300749UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
10 Tests/Kit or 20 Tests/Kit, CR026EU01
Primary DI / UDI-DI
06976968300749
Basic UDI-DI
B-06976968300749
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000053778
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shenzhen Channel Biotechnology Co., Ltd.

See all devices from Shenzhen Channel Biotechnology Co., Ltd. →

Properties

  • Reagent

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No