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JuliaOmix™ LAB

by GenomeUp Italy EUDAMED

Ref LABModel JuliaOmix™ LAB

EMDN W02079092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805889800LAB-A-001SU Basic UDI-DIDate26 May 2026RegisteredStatusActive

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™ LAB, LAB
Primary DI / UDI-DI
80588980000488
Basic UDI-DI
805889800LAB-A-001SU
Direct Marketing DI
80588980000488
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
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
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b3a1d937-e449-4f7d-92e7-ceed2abb04a0 61 fields · synced 22 Oct 2026