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VITROS™ ECL D-Dimer STAT Assay

by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED

Ref QO0320500303Model 50T，2×50T，100T，2×100T EMDN W0103020503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69703416803205040J7 Basic UDI-DIDate4 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
D-Dimer STAT (eCLIA)
Model / Reference
50T，2×50T，100T，2×100T, QO0320500303
Primary DI / UDI-DI
06978139076392
Basic UDI-DI
69703416803205040J7
EMDN Code
W0103020503 D-dimer
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005654
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Lifotronic Technology Co., Ltd.

See all devices from Shenzhen Lifotronic Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06978139076392|69703416803205040J7 61 fields · synced 24 Oct 2026