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Genvinset® Factor II G20210A 24 test

by Blackhills Diagnostic Resources S.L.U.

Ref GVS-FII-24Model Genvinset® Factor II G20210A 24 test

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437016942GVS-FIIQP Basic UDI-DI 08437016942444UDI-DIDate11 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Genvinset® Factor II G20210A
Model / Reference
Genvinset® Factor II G20210A 24 test, GVS-FII-24
Primary DI / UDI-DI
08437016942444
Basic UDI-DI
8437016942GVS-FIIQP
EMDN Code
W0106010114 Prothrombin mutation
Device Class
Class C
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

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Properties

  • 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