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Gina 500

by Cube Dx GmbH Austria EUDAMED

Ref 09120127730244Model GINA 500 EMDN W02050106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number912012773GINA7H Basic UDI-DIDate14 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Gina
Model / Reference
GINA 500, 09120127730244
Primary DI / UDI-DI
09120127730244
Basic UDI-DI
912012773GINA7H
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000013909

Other devices from Cube Dx GmbH

See all devices from Cube Dx GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b9d13aac-61e5-48e1-9793-eecb7e29adc8 61 fields · synced 22 Oct 2026