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: D006AF001A12A, WE>O, tearcheck.
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- E-One Clinic RC
- E>075
- WE>O
- tearcheck
Catalogue references include D002AF004Bxxx, D005AF001A02A, D006AF001A12A, D029AF001B13A, D036AF001A08A.
European nomenclature codes declared: Z129005, X0502, Z12040199.
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 |
Device-level evidence
| Devices with a numeric GTIN | 3 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | E-SWIN |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 2 |
| First licensed | 2020-03-19 |
Licence types: Single Device (2), System (1).
Licensed under: E-EYE C, TEARCHECK, E>O60.
North American profile: Both markets. E-SWIN SAS is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1024982-1 | cancelled | 2028-05-23 |
28620240995 | issued | 2028-05-23 |