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Genvinset® PAI-1 4G/5G 96 tests

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

Ref GVS-PAI-96Model Genvinset® PAI-1 4G/5G

EMDN W0103020299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08437016942857 Basic UDI-DIDate8 Feb 2024RegisteredStatusActive

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

Model / Reference
Genvinset® PAI-1 4G/5G, GVS-PAI-96
Primary DI / UDI-DI
08437016942857
Basic UDI-DI
B-08437016942857
EMDN Code
W0103020299 Coagulation factors - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

Other devices from Blackhills Diagnostic Resources S.L.U.

See all devices from Blackhills Diagnostic Resources S.L.U. →

Properties & raw data

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

Sources (1)

  • EUDAMED b600515e-439c-40d4-badb-c850af156473 61 fields · synced 22 Oct 2026