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: EmbraceMini FKM Band, EmbracePlus, Empatica Care - iOS Version, EpiMonitor by Empatica iOS Version, EpiMonitor powered by EmbracePlus.
Among these devices, 19 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- EmbraceMini FKM band
- EmbraceMini elastic strap
- EmbraceMini stretchable band
- EmbracePlus
- EmbracePlus Stretchable Band - Black
- EmbracePlus with Elastic Strap
- Empatica Care - Android
- EpiMonitor Flamingo pink
- EpiMonitor by Empatica
- EpiMonitor milan black
- EpiMonitor sky blue
- PKG Monitor by Empatica (Android)
Showing 12 of 19 declared devices.
Catalogue references include CARE-IOS, Care Portal, EBP2-1G-ES-F, EBP2-1G-FB-B, EMBP-CC-MS, EPI-1G-FB-MB.
European nomenclature codes declared: Z1203020601, Z121002, Z12062592, Z12040180,Z12062592, Z1203020682.
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 |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 57.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EMPATICA S.R.L. |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2026-03-19 |
Licence types: System (2).
Licensed under: EPIMONITOR, EMPATICA HEALTH MONITORING PLATFORM.
North American profile: Both markets. Empatica S.r.L. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1986726 1 | supplemented | 2029-11-28 |