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SOPHiA DDM Dx mode

by SOPHiA GENETICS SA Switzerland EUDAMED

Ref DXMode EMDN W02050182

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number762228300110AE Basic UDI-DIDate26 May 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  • Withdrawn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 25 Oct 2026

Model / Reference
DXMode
Primary DI / UDI-DI
07622283009681
Basic UDI-DI
762228300110AE
Direct Marketing DI
07622283009681
EMDN Code
W02050182 Nucleic acid testing instruments except micro-arrays - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000025221
Authorised representative
SOPHiA GENETICS SAS FR-AR-000022214

Other devices from SOPHiA GENETICS SA

See all devices from SOPHiA GENETICS SA →

Properties & raw data

Show properties, registry sources and raw records
  • New Device
Other properties (10)
  • 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

Sources (1)

  • EUDAMED c395b44b-6964-4662-8a75-f09dfcdd267e 61 fields · synced 25 Oct 2026