Regen Lab SA
CH-MF-000032231 · Switzerland · Le Mont-sur-Lausanne
Regen Lab 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 IIb | 32 |
|---|---|
| Class I | 11 |
| Class IIa | 8 |
Among these devices, 51 are declared sterile, 11 implantable, 48 active.
Authorised representative in the Union: FR-AR-000011953.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | REGEN LAB Sa (CH) · FDA 3008496303 |
| Devices in EUDAMED | 51 |
| Country of registration | Switzerland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 756199 | supplemented | 2028-04-24 |
MDR 756198 | supplemented | 2028-04-24 |
MDR 755931 | supplemented | 2028-04-24 |