Zhermack S.p.A.
IT-MF-000011215 · Italy · Badia Polesine (RO)
Zhermack S.p.A. is registered in the European database on medical devices as a manufacturer, with 254 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 254 |
|---|
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 | ZHERMACK S.P.A. (IT) · FDA 9614794 |
| Devices in EUDAMED | 254 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 053618 0030 | reissued | 2031-10-20 |
G10 053618 0028 | issued | 2026-10-20 |