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hs-cTnI Reagent kit

by Shanghai Medconn Biotechnology Co., Ltd. China EUDAMED

Ref NAModel 25 Tests /kit

EMDN W01021399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06954418517374 Basic UDI-DIDate6 Jul 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 24 Oct 2026

Device Name
hs-cTnI Reagent kit
Model / Reference
25 Tests /kit, NA
Primary DI / UDI-DI
06954418517374
Basic UDI-DI
B-06954418517374
EMDN Code
W01021399 Cardiac markers - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000038615
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 06954418517374|B-06954418517374 61 fields · synced 24 Oct 2026