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Creatine Kinase Assay Kit (DGKC Method)

by Da Te Bioengineering Technology Co., LTD. China EUDAMED

Ref DTSH040110Model R1: 60mL×4; R2: 60mL×1 EMDN W01010113

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975225461650 Basic UDI-DIDate10 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Creatine Kinase Assay Kit (DGKC Method)
Model / Reference
R1: 60mL×4, R2: 60mL×1, DTSH040110
Primary DI / UDI-DI
06975225461650
Basic UDI-DI
B-06975225461650
EMDN Code
W01010113 Creatine kinase - total
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000028832
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Da Te Bioengineering Technology Co., LTD.

See all devices from Da Te Bioengineering Technology Co., LTD. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED cca97a5e-4bca-4916-95df-0eae45be191f 61 fields · synced 24 Oct 2026