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: Accure, Light C, MultiLASE TFL, Nanostar R, Reusable Optical Fiber.
Among these devices, 196 are declared sterile, 90 active.
Devices declared under this manufacturer
- Light C
- MultiLASE TFL
- Nanostar R
- Reusable 10x Optical Fiber
- Reusable 10x Optical Fiber Performance
- Reusable 5x Optical Fiber
- Single Use CO2 Laser Fiber
- Single Use Optical Fiber
- Single Use Optical Fiber Lateral
- Single Use Optical Fiber Performance
- Surgical Laser Fiber
- Twain IPL
Showing 12 of 288 declared devices.
Catalogue references include H787VC1470PRO, HAF005001, MF1000ST, MFP272RST, MS365RST, OAF003613.
European nomenclature codes declared: Z12011080, Z12011019, Z12011003, Z12011006, Z12011016, Z12011014.
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 |
Device-level evidence
| Devices with a numeric GTIN | 288 |
|---|---|
| Found in the U.S. device database | 168 |
| Share | 58.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | QUANTA SYSTEM S.P.A. |
What it holds in Canada
| Licences on record | 26 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 22 |
| First licensed | 2010-12-02 |
Licence types: Single Device (10), Device Family (10), System (6).
Licensed under: ASSET, CYBER HO 60, OLYMPUS EMPOWER LASER SYSTEMS, CYBER HO 100, OLYMPUS EMPOWER H100, VENACURE 1470 PRO, LITHO EVO.
North American profile: Both markets. Quanta System S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 095419 0012 | issued | 2026-12-13 |