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Genvinset® PAI-1/FXIII multiplex 96 test

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

Ref GVS-PAI/F13-96Model Genvinset® PAI-1/FXIII multiplex 24 test

EMDN W0106010116

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number843661525GVS-PAI/F13UA Basic UDI-DIDate11 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Genvinset® PAI-1/FXIII multiplex
Model / Reference
Genvinset® PAI-1/FXIII multiplex 24 test, GVS-PAI/F13-96
Primary DI / UDI-DI
08436615250028
Basic UDI-DI
843661525GVS-PAI/F13UA
EMDN Code
W0106010116 Other thrombophilia mutations (proc, pros1, mthfr, serpinc1, sepine1, f11, f12, f13, other f2/f5)
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 37cdd58d-cef2-49d4-8cbd-e2de56f6d30b 61 fields · synced 22 Oct 2026