EU → North America Device Access

SAGIRES SRL

IT-MF-000030632 · Italy · roma

SAGIRES SRL is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4
Class IIa1

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 01, 02, 03, 04, 05.

European nomenclature codes declared: Z120309, Z1203019099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationItaly

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

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. SAGIRES SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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