E-SWIN SAS
FR-MF-000011807 · France · Houdan
E-SWIN SAS is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: WE>O, D006AF001A12A, tearcheck.
Among these devices, 5 are declared active.
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 | E-SWIN (FR) · FDA 3014132468 |
| Devices in EUDAMED | 5 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1024982-1 | cancelled | 2028-05-23 |
28620240995 | issued | 2028-05-23 |