BIOS Srl
IT-MF-000022514 · Italy · Vimodrone
BIOS Srl 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 IIb | 5 |
|---|
Most frequent device types declared: NuEra Tight 1ch, Alex + Nd:YAG, Feminess Tip, NuEra Tight 1chv.
Among these devices, 1 are declared sterile, 5 active.
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 | BIOS (US) · FDA 3033273230 |
| Devices in EUDAMED | 5 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
237/MDR | issued | 2030-08-24 |