Amil Care Italia S.r.l.
IT-MF-000012107 · Italy · Tradate
Amil Care Italia S.r.l. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Among these devices, 12 are declared active.
Devices declared under this manufacturer
- EVOLYSE BASIC 1L
- EVOLYSE BASIC 2L
- EVOLYSE BASIC 5L
- EVOLYSE STRONG 1L
- EVOLYSE STRONG 2L
- MAXIBIOS HUB
- MEDIBIOS PLUS.HUB
- MEDILINK PLUS
- MY LINK S
- STERILBIOS BASIC 1L
- STERILBIOS STRONG 1L
- STERILBIOS STRONG 2L
Showing 12 of 24 declared devices.
Catalogue references include 2010.41, 2010.43, 2020.21, 2021.t - 5L.link, 2022.m - hub, 2030.21.
European nomenclature codes declared: D0502, Z12011399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AMIL CARE ITALIA S.R.L. (IT) · FDA 3016510805 |
| Devices in EUDAMED | 24 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Amil Care Italia S.r.l. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
083-00-00-MDR | issued | 2030-10-13 |