SOPHiA GENETICS SA
CH-MF-000025221 · Switzerland · Rolle
SOPHiA GENETICS SA is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Authorised representative in the Union: SOPHiA GENETICS SAS.
Devices declared under this manufacturer
- SOPHiA DDM Dx mode
- SOPHiA GENETICS™ Dx Universal Library Prep
Showing 12 of 17 declared devices.
Catalogue references include BS0102ILLCGLL01-048, BS0105ILLCSML03, BS0119ILLCSRY07-32, BX6002UNICMDL30, BX6002UNICMDL30-32, BX6002UNICMDL31-16.
European nomenclature codes declared: W02050185, W01060299, W02050182.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. SOPHiA GENETICS SA was not found in either the U.S. or the Canadian register.