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C-Reactive Protein(CRP) Assay Kit(Chemiluminescent Immunoassay)

by Wuhan Life Origin Biotech Joint Stock Co., Ltd. 3 variants

Ref 50 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974986812701 Basic UDI-DI 06974986812701UDI-DIDate13 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit(Chemiluminescent Immunoassay)
Model / Reference
50 Tests/Kit
Primary DI / UDI-DI
06974986812701
Basic UDI-DI
B-06974986812701
EMDN Code
W01021109, W01021311
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000027340
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuhan Life Origin Biotech Joint Stock Co., Ltd.

See all devices from Wuhan Life Origin Biotech Joint Stock Co., Ltd. →

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