Ortho Cape
FR-MF-000028862 · France · Montauban
Ortho Cape is registered in the European database on medical devices as a manufacturer, with 256 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 214 |
|---|---|
| Class IIa | 42 |
Most frequent device types declared: EAGLE, WIRES, PPDA Screw , MI-SCREW, SBS.
Among these devices, 221 are declared sterile, 214 implantable, 32 reusable, 1 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORTHO CAPE (FR) · FDA 3027827832 |
| Devices in EUDAMED | 256 |
| Country of registration | France |