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Creatine Kinase Isoenzyme MB（CK-MB）

by Maccura Biotechnology Co., Ltd. 3 variants

Ref ECH0106211, IM4104201, IM4105201

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ECH01062115M Basic UDI-DIDate22 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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

Device Name
Creatine Kinase Isoenzyme MB（CK-MB）
Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method
Model / Reference
ECH0106211, IM4104201, IM4105201
Primary DI / UDI-DI
D-ECH01062115M, D-IM4104201GH, D-IM4105201GQ
Basic UDI-DI
B-ECH01062115M, B-IM4104201GH, B-IM4105201GQ
EMDN Code
W01021311, W0102160701
Device Class
Class IVD General
Market of Registration
Germany
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No