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SOPHiA GENETICS™ Dx Universal Library Prep

by SOPHiA GENETICS SA Switzerland EUDAMED

Ref BX6002UNICMDL30 EMDN W02050185

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7622283ULPDx7A 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  • Withdrawn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 24 Oct 2026

Model / Reference
BX6002UNICMDL30
Primary DI / UDI-DI
07622283013121
Basic UDI-DI
7622283ULPDx7A
Direct Marketing DI
07622283013121
EMDN Code
W02050185 Nucleic acid testing instruments except micro-arrays - consumables
Device Class
Class A
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
  • Reagent
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED be933303-d9b1-497f-895e-d78cb9ec3427 61 fields · synced 24 Oct 2026