Bieffe Medital S.p.A.
IT-MF-000019172 · Italy · Sondalo (SO)
Bieffe Medital S.p.A. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 13 |
|---|
Among these devices, 13 are declared sterile.
Devices declared under this manufacturer
- Prism0cal
- Prism0cal B22
- Prismocitrate
Showing 12 of 13 declared devices.
Catalogue references include 110188, 112958, 114108, 115654, 955427, 955428.
European nomenclature codes declared: F9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Bieffe Medital S.p.A. (IT) · FDA 3003591774 |
| Devices in EUDAMED | 13 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| 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: United States only. Bieffe Medital S.p.A. is registered in the United States but was not found in the Canadian register.