EU → US Device Access

AT-OS SRL

IT-MF-000028623 · Italy · COLOGNOLA AI COLLI

AT-OS SRL is registered in the European database on medical devices as a manufacturer, with 113 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa113

Most frequent device types declared: AF2, DC, ENDO 3.

Among these devices, 113 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 EUDAMED113
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.

Notified body certificates

CertificateStatusExpiry
G10 041151 0016issued2030-03-06

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