Sooma Oy
FI-MF-000004844 · Finland · Helsinki
Sooma Oy is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 21 |
|---|
Most frequent device types declared: CCBL, DCS6, PAD10, Sooma tDCS.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- ComfoCable
- ComfoCap, CCL2
- ComfoCap, CCL3
- ComfoCap, CCM0
- ComfoCap, CCM3
- ComfoCap, CCS0
- ComfoCap, CCS3
- ComfoCap, CCXS0
- ComfoCap, CCXS2
- ComfoCap, CCXS3
- ComfoPad, CP10
- ComfoTrode, B
Showing 12 of 21 declared devices.
Catalogue references include CCBL, CCL2, CCL3, CCM0, CCS0, CCXS0.
European nomenclature codes declared: Z12101102, Z12101185, Z12101106.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SOOMA OY |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2016-11-30 |
Licence types: System (1).
Licensed under: SOOMA TDCS.
North American profile: Canada only. Sooma Oy holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI23/00000033 | issued | 2028-08-29 |
FI23/00000033 | reissued | 2030-07-29 |