Bionit Labs Srl FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)510(k)Mar 12, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Mar 12, 2026
Wave Electrode (AE02-60); Wave Electrode (AE02-50)510(k)Jan 2, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 2, 2025