Luneau Technology Operations
FR-MF-000009091 · France · Pont-de-l'Arche
Luneau Technology Operations is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 52 |
|---|
Most frequent device types declared: DNEye Scanner 2+, DNEye Scanner 3, EyeRefract, L900, RETINA 800.
Among these devices, 1 are declared sterile, 31 active, 20 with a measuring function.
Devices declared under this manufacturer
- 22 universal prisms rounded shape – includes Red Lens
- Black plastic occluder with plain handle
- DNEye Scanner 2+
- DNEye Scanner 3
- EyeRefract
- Horizontal prism bar (45 dpt)
- Parinaud set with frame
- Perimetric occluder
- RETINA 800
- TONOJET
- Translucent spielmann occluder
- VX220
Showing 12 of 52 declared devices.
Catalogue references include 7190017, 8630-1139-05, 8630-1612-10, 8630-1612-51, DNEye Scanner 3, L900.
European nomenclature codes declared: Q0299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LUNEAU TECHNOLOGY OPERATIONS (FR) · FDA 3009173773 |
| Devices in EUDAMED | 52 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 52 |
|---|---|
| Found in the U.S. device database | 31 |
| Share | 59.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LUNEAU TECHNOLOGY OPERATIONS |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 9 |
| First licensed | 2022-01-17 |
Licence types: Single Device (5), Device Family (3), System (1).
Licensed under: VX120+, AUTOREFRACTOMETER, EYEREFRACT, VX90, VX130+, VX650.
North American profile: Both markets. Luneau Technology Operations is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
160/MDR | issued | 2029-05-15 |