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Creatine Kinase Isoenzyme MB Assay Reagent Kit (Immunosuppression Method)

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref R03615Model R1: 25ml×4, R2: 25ml×1

EMDN W01010115

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R0361527 Basic UDI-DIDate30 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Creatine Kinase Isoenzyme MB Assay Reagent Kit (Immunosuppression Method)
Model / Reference
R1: 25ml×4, R2: 25ml×1, R03615
Primary DI / UDI-DI
D-R0361527
Basic UDI-DI
B-R0361527
EMDN Code
W01010115 Creatine kinase isoenzymes
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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 D-R0361527|B-R0361527 61 fields · synced 23 Oct 2026