Skip to content

D-Dimer Test Kit (Fluorescence Immunoassay)

by Wuxi Biohermes Bio & Medical Technology Co., Ltd. China EUDAMED

Ref BF-S063Model BF S06

EMDN W0103020803

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNMF000014455-BF-S063RP Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
D-Dimer Test Kit (Fluorescence Immunoassay)
Model / Reference
BF S06, BF-S063
Primary DI / UDI-DI
D-CNMF000014455-BF-S063RP
Basic UDI-DI
B-CNMF000014455-BF-S063RP
EMDN Code
W0103020803 D-dimer - rt & poc
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000014455
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd.

See all devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED D-CNMF000014455-BF-S063RP|B-CNMF000014455-BF-S063RP 61 fields · synced 24 Oct 2026