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: Alex + Nd:YAG, Feminess Tip, NuEra Tight 1ch, NuEra Tight 1chv.
Among these devices, 1 are declared sterile, 5 active.
Devices declared under this manufacturer
- Feminess Tip
- NuEra Tight
- NuEra Tight Feminess
- OptiPLUS
- SPLENDOR X
Catalogue references include AE0204, APMD122.SPX-2.0, APMD145-1ch, APMD145-1ch-OptiPLUS, APMD145-1chv.
European nomenclature codes declared: V9099,Z12040203, Z12040201, U0899, U0899,V9099,Z12040203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOS (US) · FDA 3033273230 |
| Devices in EUDAMED | 5 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOS SRL |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 3 |
| First licensed | 2021-08-18 |
Licence types: System (2), Single Device (1).
Licensed under: NUERA TIGHT 1CH, SPLENDOR X LASER FAMILY, OPTIPLUS.
North American profile: Both markets. BIOS Srl is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
237/MDR | issued | 2030-08-24 |