Empatica S.r.L.
IT-MF-000012905 · Italy · Milan
Empatica S.r.L. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 19 |
|---|
Most frequent device types declared: EmbracePlus, EpiMonitor powered by EmbracePlus, Empatica Care - iOS Version, EmbraceMini FKM Band, EpiMonitor by Empatica iOS Version.
Among these devices, 19 are declared active, 4 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 | EMPATICA S.r.l. (IT) · FDA 3012933969 |
| Devices in EUDAMED | 19 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1986726 1 | supplemented | 2029-11-28 |