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Genvinset® FIIFV multiplex 24 test

by Blackhills Diagnostic Resources S.L.U. Spain EUDAMED

Ref GVS-FIIFV-24Model Genvinset® FIIFV multiplex EMDN W0103020299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437016942GVS-FIIFVPK Basic UDI-DIDate31 Oct 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Genvinset® FIIFV multiplex
Model / Reference
Genvinset® FIIFV multiplex, GVS-FIIFV-24
Primary DI / UDI-DI
08437016942765
Basic UDI-DI
8437016942GVS-FIIFVPK
EMDN Code
W0103020299 Coagulation factors - other
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

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Properties & raw data

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

Sources (1)

  • EUDAMED bdae977a-0fba-40be-b0ad-7b2350021fec 61 fields · synced 22 Oct 2026