BionIT Labs S.r.l.
IT-MF-000007793 · Italy · Soleto
BionIT Labs S.r.l. is registered in the European database on medical devices as a manufacturer, with 373 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 373 |
|---|
Most frequent device types declared: AH02-CDY-EE-WW, AE02-NN-WW, EB02-E-WW, MU01-WW.
Among these devices, 357 are declared 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 | BIONIT LABS S.R.L. (IT) · FDA 3018070844 |
| Devices in EUDAMED | 373 |
| Country of registration | Italy |