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Genvinset® HLA Celiac 24 tests

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

Ref GVS-DQ-24Model Genvinset® HLA Celiac

EMDN W0106010401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437016942GVS-DQEB Basic UDI-DIDate30 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® HLA Celiac
Model / Reference
Genvinset® HLA Celiac, GVS-DQ-24
Primary DI / UDI-DI
08437016942093
Basic UDI-DI
8437016942GVS-DQEB
EMDN Code
W0106010401 Hla-typing
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 ec44a51a-3aff-4e23-98a0-d3805eeba354 61 fields · synced 22 Oct 2026