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AOTI Limited

IE-MF-000025075 · Ireland · Galway

AOTI Limited is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Hyper-Box System.

Among these devices, 22 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 entryAOTI LTD. (IE) · FDA 3006538358
Devices in EUDAMED22
Country of registrationIreland

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