EU → US 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, TUBING EXTENSION FOR MECHANICAL IRRIGATION SET, Spunbond cap with laces, SMS surgical gown, SMS pyjamas.

Among these devices, 64 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED116
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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