Skip to content

Creatine kinase-MB (CK-MB) Test Kit (Chemiluminescence)

by Nanjing Norman Biological Technology Co., Ltd. EUDAMED 3 variants

Active European Union

Ref 22301310200083Model 50×2tests/box

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06921893005498 Basic UDI-DIDate25 Aug 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  • Withdrawn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

Model / Reference
50×2tests/box, 22301310200083
Primary DI / UDI-DI
06921893005498
Basic UDI-DI
B-06921893005498
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class IVD General
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000024233
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Nanjing Norman Biological Technology Co., Ltd.

See all devices from Nanjing Norman Biological Technology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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