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D-Dimer Rapid Test Kit (Fluorescence Immunochromatographic Assay)

by Hoyotek Biomedical Co., Ltd. China EUDAMED

Ref IF14-01-40Model Please see the IFU. EMDN W0103020503

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974738205126 Basic UDI-DIDate8 Sep 2023RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Fluorescence Immunochromatography Analyzer
Model / Reference
Please see the IFU., IF14-01-40
Primary DI / UDI-DI
06974738205126
Basic UDI-DI
B-06974738205126
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003570
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hoyotek Biomedical Co., Ltd.

See all devices from Hoyotek Biomedical Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 6d2a3b7b-a4ea-4505-85f8-c42ecafabfb5 61 fields · synced 25 Oct 2026