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: FibroScan 230, FibroScan 430, FibroScan 530 Compact, FibroScan 630, M+ Probe.
Among these devices, 13 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- FibroScan
Showing 12 of 14 declared devices.
Catalogue references include FibroScan 230, FibroScan 430 Mini, FibroScan 530 Compact, FibroScan 630, M+ Probe, S+ Probe.
European nomenclature codes declared: Z12040199, Z12040182.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ECHOSENS (FR) · FDA 3010258456 |
| Devices in EUDAMED | 14 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 12 |
| Share | 85.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ECHOSENS |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2009-07-08 |
Licence types: Device Family (2), System (1).
Licensed under: FIBROSCAN TRANSIENT ELASTOGRAPHY DEVICES, FIBROSCAN PROBES, FIBROSCAN 630.
North American profile: Both markets. Echosens is registered in both the United States and Canada.