EU → US Device Access

M.A.X.Oto Otocostruzioni Srl

IT-MF-000034338 · Italy · Napoli

M.A.X.Oto Otocostruzioni Srl is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: Endo SINFONY PLUS PLUS, CIC SINFONY PLUS PLUS, Retro Micro One Bionica, Retro Micro One Sinfony Plus Plus, Endo SINFONY PLUS.

Among these devices, 16 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 registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationItaly
⚠️ 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 Italy

All Italy manufacturers →