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Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)

by Jiangsu Confidence Medical Technology Co., Ltd China EUDAMED

Ref 25 tests/kit

EMDN W01010115

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06979355928090 Basic UDI-DIDate21 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Creatine kinase myocardial isoenzyme (CKMB) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)
Model / Reference
25 tests/kit
Primary DI / UDI-DI
06979355928090
Basic UDI-DI
B-06979355928090
EMDN Code
W01010115 Creatine kinase isoenzymes
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050949
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED fe10d804-abfc-4583-b772-fc3f581341b2 61 fields · synced 22 Oct 2026