EU → North America 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, 90222GMH, 90222SHH, 90275XVH, 93053GB.

Among these devices, 116 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 116 declared devices.

Catalogue references include 90152GMH, 90275XVH, 93053GB, 93106RH, 93578LT, 93785GM.

European nomenclature codes declared: Q02030204, Q0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED116
Country of registrationIreland

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

Device-level evidence

Devices with a numeric GTIN22
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. AMO Ireland was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
G10 001630 0013issued2029-02-01

Other manufacturers in Ireland

All Ireland manufacturers →