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: AE02-NN-WW, AH02-CDY-EE-WW, EB02-E-WW, MU01-WW.
Among these devices, 357 are declared active.
Devices declared under this manufacturer
- Adam's Hand
- Adam's Hand Plus
- Adam's Skin
- Adam's Skin Plus
- Analog Amplifier
- Anlog Amplifier
- Myo Unit
- MyoLogic
- MyoLogic Pro
- Pulse Hub
- Remote Wave Electrode
- ThunderCell Battery
Showing 12 of 373 declared devices.
Catalogue references include AE03-50-01, AH02-LM3-W1-01, AH02-LS1-N7-01, AH02-LS3-B1-01-L, AH02-LS3-N1-01, AH03-RS1-N2-01.
European nomenclature codes declared: Y061899, N010101, Y061809, V06010199.
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 |
Device-level evidence
| Devices with a numeric GTIN | 373 |
|---|---|
| Found in the U.S. device database | 91 |
| Share | 24.4 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. BionIT Labs S.r.l. is registered in the United States but was not found in the Canadian register.