Quantum Surgical SAS
FR-MF-000000600 · France · montpellier
Quantum Surgical SAS is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: 02-0026, 02-0027, 30-0001, 30-0004.
Among these devices, 7 are declared active.
Devices declared under this manufacturer
- EPIONE
- NEEDLE HOLDER H12
- NEEDLE HOLDER H22
- NEEDLE HOLDER H42
Showing 12 of 15 declared devices.
Catalogue references include 02-0026, 02-0031, 02-0044, 02-0084, 02-0085, 02-0086.
European nomenclature codes declared: Z12011480, Z12011401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | QUANTUM SURGICAL SAS (FR) · FDA 3023140882 |
| Devices in EUDAMED | 15 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 20.0 % |
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. Quantum Surgical SAS is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1551912-1 | reissued | 2031-08-30 |