Sisma S.p.A.
IT-MF-000038326 · Italy · Mantova
Sisma S.p.A. is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 26 |
|---|
Devices declared under this manufacturer
- Acqua e Sapone Cotone medicale pretagliato
- Acqua e Sapone quadrotto in cotone medicale
- CARESYA
- COAL COTONE IDROFILO MEDICALE
- COAL FALDINE MEDICALE IN COTONE
- COOP COTONE MEDICALE PRETAGLIATO
- COOP FALDINE DI COTONE PER USO MEDICALE
- ESSELUNGA COTONE MEDICALE PRETAGLIATO
- FARMACOTONE QUADROTTO IN COTONE MEDICALE
- Farmacotone cotone idrofilo
- IL FARMACOTONE COTONE BIOLOGICO
- Il Farmacotone cotone idrofilo medicale
Showing 12 of 26 declared devices.
Catalogue references include 1501INS, 1506AES, 1520/SL, 1520CARE, 1520COAL, 1520VEGE.
European nomenclature codes declared: M010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 26 |
| 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 | 26 |
|---|---|
| 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. Sisma S.p.A. was not found in either the U.S. or the Canadian register.