EU → North America Device Access

TENORTHO SRL

IT-MF-000050082 · Italy · BIASSONO

TENORTHO SRL is registered in the European database on medical devices as a manufacturer, with 522 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa522

Most frequent device types declared: TO1205, TO2114, TO2200, TO2301, TO3113.

Devices declared under this manufacturer

Showing 12 of 522 declared devices.

Catalogue references include TO1205_XL, TO2114_0DX, TO2200_XLSX, TO2301_LDX, TO3113_S, TO3117_S.

European nomenclature codes declared: Y061209, Y060399, Y06120601, Y060609, Y060308, Y060309.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED522
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 GTIN522
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. TENORTHO SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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