WISE S.p.A.
IT-MF-000012628 · Italy · Cologno Monzese
WISE S.p.A. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 3 |
|---|---|
| Class IIa | 2 |
Among these devices, 4 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | WISE S.p.A. (IT) · FDA 3030387292 |
| Devices in EUDAMED | 5 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
70944 | issued | 2031-04-20 |
1434-MDR-006/2025 | issued | 2030-06-17 |
1434-MDR-005/2025 | amended | 2030-06-17 |