Esaote S.p.A.
IT-MF-000019024 · Italy · Genova
Esaote S.p.A. is registered in the European database on medical devices as a manufacturer, with 310 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 309 |
|---|---|
| Class I | 1 |
Most frequent device types declared: 6440, 66xx, 6450E, 6450, 7400.
Among these devices, 309 are declared active, 2 with a measuring function.
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 | ESAOTE S.P.A. (IT) · FDA 8043485 |
| Devices in EUDAMED | 310 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 095545 0032 | reissued | 2031-08-24 |
G10 095545 0024 | issued | 2026-08-24 |