EU → US Device Access

LABORATORIA BOTA NV

BE-MF-000000263 · Belgium · DEINZE

LABORATORIA BOTA NV is registered in the European database on medical devices as a manufacturer, with 694 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa694

Most frequent device types declared: BOTA STOCKINGS, BOTA BRACES, BOTA PODIATRY, BOTA WALKINGAIDS, BOTA CUSHIONS.

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 registerNot found in the FDA register
Devices in EUDAMED694
Country of registrationBelgium
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Belgium

All Belgium manufacturers →