Bien-Air Surgery SA
CH-MF-000016376 · Switzerland · Le Noirmont
Bien-Air Surgery SA is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 51 |
|---|
Most frequent device types declared: PM2 Burs, Cables, PM2 Handpieces , PM PERFO Cable, S120 Cable.
Among these devices, 22 are declared sterile, 4 reusable, 2 active.
Authorised representative in the Union: FR-AR-000011942.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIEN-AIR SURGERY SA (CH) · FDA 3003800209 |
| Devices in EUDAMED | 51 |
| Country of registration | Switzerland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CH23/00001091 | issued | 2028-08-11 |