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_Broach_Handle, Hip_Calcar Reamer, Hip_Femoral Broach, Hip_Femoral Reamer, Hip_Reamer Handle.
Among these devices, 1 are declared sterile, 1 implantable, 107 reusable.
Devices declared under this manufacturer
- Cylindrical reamer Ø10
- Cylindrical reamer Ø12
- Cylindrical reamer Ø18
- INITIALE Broach – Dual Offset – Left – Size 102S
- INITIALE Broach – Dual Offset – Left – Size 302S
- INITIALE Broach – Dual Offset – Right – Size 201S
- INITIALE Trial neck size 30
- INITIALE Trial neck size 50
- INITIALE dysplasia femoral broach N° 121D
- INITIALE modular broach N° 201
- INITIALE modular broach N° 303
- INITIALE modular broach N° 601
Showing 12 of 108 declared devices.
Catalogue references include 2-0109110, 2-0109118, 2-0150221, 2-1100221, 8-0101221, 8-0101233.
European nomenclature codes declared: L091199, L090999, L098099, L091101, L091104, L0921.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AMPLITUDE (FR) · FDA 3009590742 |
| Devices in EUDAMED | 108 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 108 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AMPLITUDE |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 9 |
| Class 3 devices | 1 |
| First licensed | 2019-02-05 |
Licence types: Device Family (8), System (2).
Licensed under: ANATOMIC POSTERIOR STABILIZED TOTAL KNEE PROST, NOTCH REAMER FOR ANATOMIC TOTAL KNEE PROSTHESI, TRIAL INSERTS FOR ANATOMIC POSTERIOR STABILIZE, DRILL BIT FOR ANATOMIC POSTERIOR STABILIZED TO, PINS FOR ANATOMIC TOTAL KNEE PROSTHESIS, PIN DRIVERS FOR ANATOMIC TOTAL KNEE PROSTHESIS.
North American profile: Both markets. AMPLITUDE is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 822547 | supplemented | 2030-06-03 |