SIGVARIS SAS
FR-MF-000023834 · France · Saint Just Saint Rambert
SIGVARIS SAS is registered in the European database on medical devices as a manufacturer, with 3 018 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 018 |
|---|
Most frequent device types declared: Sigvaris Styles transparent 15-20 mmHg, Sigvaris Essentiel semi-transparent 15-20 mmHg, Dynaven transparent 15-20 mmHg, Sigvaris Styles opaque 15-20 mmHg, Sigvaris Essentiel semi-transparent 20-36 mmHg.
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 | SIGVARIS AG (CH) · FDA 8031005 |
| Devices in EUDAMED | 3 018 |
| Country of registration | France |