Skip to content

D-Dimer Rapid Quantitative Test (Fluorescence Immunoassay)

by Xiamen BioRay Biotechnology Co., Ltd. China EUDAMED

Ref HR0201901

EMDN W0102160799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977194141717 Basic UDI-DIDate25 Oct 2025RegisteredStatusActive

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 22 Oct 2026

Device Name
D-Dimer Rapid Quantitative Test (Fluorescence Immunoassay)
Model / Reference
HR0201901
Primary DI / UDI-DI
06977194141717
Basic UDI-DI
B-06977194141717
EMDN Code
W0102160799 Cardiac markers - rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000045502
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Xiamen BioRay Biotechnology Co., Ltd.

See all devices from Xiamen BioRay 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 55e20d6f-df92-4293-9f6f-bffbf8f38519 61 fields · synced 22 Oct 2026