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hyborg Dx RED2

by Cube Dx GmbH Austria EUDAMED

Ref 09120127730015Model hyborg Dx RED EMDN W02050201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number912012773HDR-001XD Basic UDI-DIDate8 Nov 2023RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Model / Reference
hyborg Dx RED, 09120127730015
Primary DI / UDI-DI
09120127730015
Basic UDI-DI
912012773HDR-001XD
Direct Marketing DI
09120127730015
EMDN Code
W02050201 Micro-array analysers
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
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 7c92ee9e-e820-43fc-82e6-2be32d04aacd 61 fields · synced 23 Oct 2026