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SOPHiA DDM DX Homologous Recombination Deficiency Solution

by SOPHiA GENETICS SA

Ref BS0121ILLCSMY08-32

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BS0121ILLCSMY08-323Q Basic UDI-DI D-BS0121ILLCSMY08-323QUDI-DIDate24 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
SOPHiA DDM DX Homologous Recombination Deficiency Solution
Model / Reference
BS0121ILLCSMY08-32
Primary DI / UDI-DI
D-BS0121ILLCSMY08-323Q
Basic UDI-DI
B-BS0121ILLCSMY08-323Q
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

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

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Properties

  • 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