EU → North America Device Access

SA.GE srl

IT-MF-000030827 · Italy · Cavezzo

SA.GE srl is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa31

Most frequent device types declared: Famiglia Forbici Stringitubo, Famiglia Medicazione, Famiglia Premifistola.

Catalogue references include AC 150 V DA 800, AC 155 V 600 pz., AC 165 B DA 30, AC 165 V 100 PZ., AC 165 V DA 200 PZ, AC 170 LV 1000 PZ.

European nomenclature codes declared: F9080, V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED31
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 GTIN31
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. SA.GE srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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