EU → US Device Access

AMO Ireland

IE-MF-000013704 · Ireland · Co. Dublin

AMO Ireland is registered in the European database on medical devices as a manufacturer, with 116 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb116

Most frequent device types declared: 90152GMH, 93053GB, 94325GM, 93785GM, 93106RH.

Among these devices, 116 are declared sterile.

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 EUDAMED116
Country of registrationIreland
⚠️ 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 001630 0013issued2029-02-01

Other manufacturers in Ireland

All Ireland manufacturers →