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iStar-D-dimer

by Shenzhen Drawray Biotech Co., Ltd. China EUDAMED

Ref DC76053Model 30 Tests/kit, 30 Tests

EMDN W0103020503

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number6973224890019AF Basic UDI-DIDate14 Jan 2026RegisteredStatusActive
European UnionCE/IVDR Number6973224890019AF Basic UDI-DIDate14 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
30 Tests/kit, DC76053, 30 Tests
Primary DI / UDI-DI
06973224892390, D-DC76053FG
Basic UDI-DI
6973224890019AF, B-DC76053FG
EMDN Code
W0103020503 D-dimer
Device Class
Class C
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008763
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Drawray Biotech Co., Ltd.

See all devices from Shenzhen Drawray Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED b5ad8cc6-699e-4756-b0bb-f967903b7e0a 61 fields · synced 23 Oct 2026
  • EUDAMED D-DC76053FG|B-DC76053FG 61 fields · synced 24 Oct 2026