AMPLITUDE
FR-MF-000003453 · France · VALENCE
AMPLITUDE is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 107 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Hip_Femoral Broach, Hip_Trial Femoral Stem, Hip_Trial Femoral Stem_Revision, Hip_Trial Neck, Hip_Femoral Reamer.
Among these devices, 1 are declared sterile, 1 implantable, 107 reusable.
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 | AMPLITUDE (FR) · FDA 3009590742 |
| Devices in EUDAMED | 108 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 822547 | supplemented | 2030-06-03 |