EU → US Device Access

A.T.S. Applicazione Tecnologie Speciali s.r.l.

IT-MF-000010734 · Italy · Torre de' Roveri

A.T.S. Applicazione Tecnologie Speciali s.r.l. is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb137
Class IIa2

Most frequent device types declared: ARCO FP, ARCO FP-S, CYBERBLOC FP, CARMEX RK FP, OMNISCOP FP.

Among these devices, 139 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 registerRegistered with FDA
Matched entryA.T.S. Applicazione Tecnologie Speciali s.r.l. (IT) · FDA 3011347852
Devices in EUDAMED139
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
ITH 2492603 1supplemented2028-12-10

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