Skip to content

cTnI/NT-proBNP/D-Dimer Reagent kit

by Shanghai Medconn Biotechnology Co., Ltd. China EUDAMED

EMDN W01029099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06954418517404 Basic UDI-DIDate17 Aug 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  • Withdrawn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 22 Oct 2026

Device Name
cTnI/NT-proBNP/D-Dimer Reagent kit
Primary DI / UDI-DI
06954418517404
Basic UDI-DI
B-06954418517404
EMDN Code
W01029099 Immunochemistry reagents - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000038615
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

Other devices from Shanghai Medconn Biotechnology Co., Ltd.

See all devices from Shanghai Medconn Biotechnology Co., Ltd. →

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 7d34c492-4281-4456-b397-77bbad3914fc 61 fields · synced 22 Oct 2026