Skip to content

Creatine kinase MB(CLIA)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED

Active European Union

Ref 105-005679-00Model 105-005662-00、105-005679-00、105-005913-00

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040004L-CK-MB*****BS Basic UDI-DIDate19 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Creatine kinase MB(CLIA)、CK-MB Calibrators
Model / Reference
105-005662-00、105-005679-00、105-005913-00, 105-005679-00
Primary DI / UDI-DI
06944904065366
Basic UDI-DI
69449040004L-CK-MB*****BS
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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