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Genvinset® ApoE 48 tests

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

Ref GVS-APOE-48Model Genvinset® ApoE

EMDN W0106010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number843661525GVS-APOE4G Basic UDI-DIDate11 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Genvinset® ApoE 24 tests
Model / Reference
Genvinset® ApoE, GVS-APOE-48
Primary DI / UDI-DI
08436615250172
Basic UDI-DI
843661525GVS-APOE4G
EMDN Code
W0106010201 Alzheimer's disease
Device Class
Class C
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 (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 3ed03986-ac82-4bb3-a791-0dcd5756eadd 61 fields · synced 23 Oct 2026