Medacta International SA
CH-MF-000033473 · Switzerland · Castel San Pietro
Medacta International SA is registered in the European database on medical devices as a manufacturer, with 8 486 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 558 |
|---|---|
| Class IIb | 2 922 |
| Class I | 6 |
Most frequent device types declared: Spine MUST screw (tulip), Knee Cutting guide TKA - sterile, Knee Cutting guide TKA - not sterile, Spine MUST LT pedicle screw, Spine MUST rod.
Among these devices, 5 564 are declared sterile, 2 928 implantable, 394 reusable.
Authorised representative in the Union: IT-AR-000022505.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDACTA INTERNATIONAL SA (CH) · FDA 3008110533 |
| Devices in EUDAMED | 8 486 |
| Country of registration | Switzerland |