EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 113 declared devices.

Catalogue references include 111102027, 111102028, 111502008, 111504108, 112104012, 112104209.

European nomenclature codes declared: Z12011301, Z12019099, Z12011314.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED113
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN113
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. AT-OS SRL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
G10 041151 0016issued2030-03-06

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