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Genvinset® HFE S65C 96 test

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

Ref GVS-S65C-96Model Genvinset® HFE S65C

EMDN W0106010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437016942GVS-S65CZR Basic UDI-DIDate31 Oct 2023RegisteredStatusActive

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® HFE S65C
Model / Reference
Genvinset® HFE S65C, GVS-S65C-96
Primary DI / UDI-DI
08437016942758
Basic UDI-DI
8437016942GVS-S65CZR
EMDN Code
W0106010105 Haemochromatosis
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

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 5415d788-5e85-4f71-a4a8-111414644aaf 61 fields · synced 22 Oct 2026