Barco NV
BE-MF-000000690 · Belgium · Kortrijk
Barco NV is registered in the European database on medical devices as a manufacturer, with 350 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 346 |
|---|
Most frequent device types declared: Clinical Review Display, Intuitive workflow tools SW, Medical calibration and QA SW, Nexxis OR, Pathology Display.
Among these devices, 346 are declared active.
Devices declared under this manufacturer
- Barco
- Coronis
- Coronis Uniti
- Eonis
- Eonis 32”
- Eonis 3D
- Nexxis OR
- Nio
- Nio 5.8MP Gray
- Nio Color 8MP
- QAWeb Enterprise
- Steris
Showing 12 of 350 declared devices.
Catalogue references include K9300340A, K9300342A, K9301638B1X, K9301680A, K9303154A, K9303310B.
European nomenclature codes declared: Z11900802, Z11069099, Z11900801, Z12019099, Z11069082, W0202050380.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Barco, Inc (US) · FDA 3004578804 |
| Devices in EUDAMED | 350 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 350 |
|---|---|
| Found in the U.S. device database | 322 |
| Share | 92.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BARCO INC. |
North American profile: Both markets. Barco NV is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 082788 0022 | issued | 2028-01-26 |