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CK-MB Quantitative Test Kit (Time-Resolved FIA)

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref FDCKM-402a EMDN W01021311

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FDCKM-402aHGTK Basic UDI-DIDate21 May 2026RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Model / Reference
FDCKM-402a
Primary DI / UDI-DI
D-FDCKM-402aHGTK
Basic UDI-DI
B-FDCKM-402aHGTK
EMDN Code
W01021311 Creatine kinase - mb mass (ic)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties & raw data

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

Sources (1)

  • EUDAMED 10d8c5a7-f1dd-4dfe-a8e5-860d093e2421 61 fields · synced 23 Oct 2026