SOLTEC S.r.l.
IT-MF-000018179 · Italy · Milano
SOLTEC S.r.l. is registered in the European database on medical devices as a manufacturer, with 226 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 224 |
|---|---|
| Class IIb | 2 |
Among these devices, 224 are declared active.
Devices declared under this manufacturer
- SMEG
- SONICA
- SONICA Stream Pulse
- SONICA TRENDMATIC 18
- SONICA TRENDMATIC 9
- Sonica® S.A.M. 3 L
- Sonica® TRENDMATIC 9 TD
Showing 12 of 226 declared devices.
Catalogue references include 2200 M S3 SC V2, 2200 MHD S3 TT V2, 2400 M S3 ES V2, 4300 EP S3 BE V2, 4300 iEP S3 ST V2, 5200 ETH S3 SC V2.
European nomenclature codes declared: Z12011302.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 226 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 226 |
|---|---|
| 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. SOLTEC S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030140-00 | issued | 2030-07-30 |