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: 1601048, 1601082, Cables, PM PERFO Cable, PM2 Burs.
Among these devices, 22 are declared sterile, 4 reusable, 2 active.
Authorised representative in the Union: Bien-Air Europe Sàrl.
Devices declared under this manufacturer
- 80K / RAPIDO / PM PERFO Cable
- 80K / RAPIDO Cable 5m 10poles
- BASCH Cable
- Bur PM2-MIS P160 Mstick 1.8St
- Bur PM2-MIS P160 Mstick 3.0St
- Bur PM2-MIS P160 diam 3.0 St
- Bur PM2-MIS P160 diam C 4.0St
- BurPM2-MIS 150 steel 3.0 St
- Cable for Perforator Motor
- Connecting Cable INTRA
- NANO Cable
- OSSEOSTAP Tray
Showing 12 of 51 declared devices.
Catalogue references include 1100499, 1100684, 1100685, 1502375, 1600342-001, 1600519-001.
European nomenclature codes declared: V0199, Z12019099, V0402, Z12149099.
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 |
Device-level evidence
| Devices with a numeric GTIN | 51 |
|---|---|
| Found in the U.S. device database | 42 |
| Share | 82.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIEN-AIR SURGERY SA |
North American profile: Both markets. Bien-Air Surgery SA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CH23/00001091 | issued | 2028-08-11 |