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SOPHiA DDM Dx Myeloid Solution

by SOPHiA GENETICS SA Switzerland EUDAMED

Ref BS0103ILLCSML01 EMDN W01060299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BS0103ILLCSML01XL Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SOPHiA DDM Dx Myeloid Solution
Model / Reference
BS0103ILLCSML01
Primary DI / UDI-DI
D-BS0103ILLCSML01XL
Basic UDI-DI
B-BS0103ILLCSML01XL
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-BS0103ILLCSML01XL|B-BS0103ILLCSML01XL 61 fields · synced 24 Oct 2026