ASSUT EUROPE SPA
IT-MF-000018178 · Italy · Rome
ASSUT EUROPE SPA is registered in the European database on medical devices as a manufacturer, with 5 673 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class I | 5 673 |
|---|
Among these devices, 5 673 are declared sterile, 5 673 implantable.
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 | Similar name found — unverified |
|---|---|
| Matched entry | Assut Europe S.P.A. (IT) · FDA 9617547 |
| Devices in EUDAMED | 5 673 |
| Country of registration | Italy |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CVD0060260126 | issued | 2028-08-07 |
CVD0051260326 | supplemented | 2028-08-07 |
CVD0050250126 | supplemented | 2028-08-07 |
CVD0049250126 | supplemented | 2028-08-07 |
CVD0048250326 | supplemented | 2028-08-07 |
CVD004725 | issued | 2028-08-07 |
CVD0044250226 | supplemented | 2028-08-07 |
CVD0041240324 | supplemented | 2028-08-07 |