Quanta System S.p.A.
IT-MF-000007393 · Italy · Samarate
Quanta System S.p.A. is registered in the European database on medical devices as a manufacturer, with 288 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 198 |
|---|---|
| Class IIb | 90 |
Most frequent device types declared: Reusable Optical Fiber, Single Use Optical Fiber, Twain IPL, Cyber Ho - Litho Multicavity, Light C.
Among these devices, 196 are declared sterile, 90 active.
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 | QUANTA SYSTEM, S.P.A. (IT) · FDA 3004378299 |
| Devices in EUDAMED | 288 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 095419 0012 | issued | 2026-12-13 |