Echosens
FR-MF-000003894 · France · Paris
Echosens is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: Probes, FibroScan 530 Compact, FibroScan 430, FibroScan 230, FibroScan 630.
Among these devices, 13 are declared active, 1 with a measuring function.
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 | ECHOSENS (FR) · FDA 3010258456 |
| Devices in EUDAMED | 14 |
| Country of registration | France |