EU → North America Device Access

ALLE S.R.L.

IT-MF-000009969 · Italy · Sandrigo

ALLE S.R.L. 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 IIa116

Most frequent device types declared: IRRIGATION SET FOR MACHINERY, Implantology set, MANUAL IRRIGATION SET, Manual irrigation set, SMS surgical gown.

Among these devices, 64 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 116 declared devices.

Catalogue references include 1091018, 2701XX, 2702XX, 270426, 270634, 270902.

European nomenclature codes declared: A03010299, T020401, T0207, A03010105, T030102, T0202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED116
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. ALLE S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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