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Genvinset® HFE H63D 48 tests

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

Ref GVS-H63D-48Model Genvinset® HFE H63D

EMDN W0106010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08437016942185 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® HFE H63D, GVS-H63D-48
Primary DI / UDI-DI
08437016942185
Basic UDI-DI
B-08437016942185
EMDN Code
W0106010499 Polymorphism tests - 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 21fe08d5-1ba3-49b9-bc11-6de27347c971 61 fields · synced 22 Oct 2026