ROBOCATH S.A.S
FR-MF-000003651 · France · ROUEN
ROBOCATH S.A.S is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 7 |
Among these devices, 3 are declared sterile, 7 active.
Devices declared under this manufacturer
- Kit Consommable R-One
- R-One Robotic Platform
- R-One Robotplatform
Catalogue references include RBH01C0000, RBH01P0000, RBH01P0001.
European nomenclature codes declared: Z12059099, Z12059085.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. ROBOCATH S.A.S was not found in either the U.S. or the Canadian register.