ELESTA SpA
IT-MF-000037909 · Italy · CALENZANO
ELESTA SpA is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: EI KT0 0010 xxx, EI GU2 0008 xxx, EI KT0 0005 020.
Among these devices, 10 are declared sterile, 1 active.
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 | ELESTA SPA (IT) · FDA 3015077548 |
| Devices in EUDAMED | 15 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT343885 | issued | 2030-07-08 |