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JuliaOmix™ TRK

by GenomeUp Italy EUDAMED

Ref TRKModel JuliaOmix™ TRK

EMDN W02069082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805889800JO-TRK-0015Z Basic UDI-DIDate11 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
JuliaOmix™ TRK, TRK
Primary DI / UDI-DI
80588980000174
Basic UDI-DI
805889800JO-TRK-0015Z
Direct Marketing DI
80588980000174
EMDN Code
W02069082 Various sample processing instruments - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000046537

Other devices from GenomeUp

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED f8727ad1-a2e8-4c49-9b75-713c2d8fce7e 61 fields · synced 22 Oct 2026