Adler Ortho S.p.A
IT-MF-000010164 · Italy · Cormano (MI)
Adler Ortho S.p.A is registered in the European database on medical devices as a manufacturer, with 2 786 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 2 000 |
|---|---|
| Class IIb | 786 |
Most frequent device types declared: GENUS PANTHEON CCK MOBILE TIBIAL INSERT SIZE 4 H20, APTA ANATOMICAL CEMENTLESS STEM HA COATED SIZE 1 RIGHT, GENUS PANTHEON CCK MOBILE TIBIAL INSERT SIZE 1 H20, GENUS PANTHEON CCK MOBILE TIBIAL INSERT SIZE 5 H17, GENUS PANTHEON CCK MOBILE TIBIAL INSERT SIZE 6 H12.
Among these devices, 2 786 are declared sterile, 2 784 implantable, 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 | ADLER ORTHO S.P.A. (IT) · FDA 3008281151 |
| Devices in EUDAMED | 2 786 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
001-00-01-MDR | supplemented | 2027-03-31 |