EU → US Device Access

Physion S.R.L.

IT-MF-000022194 · Italy · Mirandola (MO)

Physion S.R.L. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: C-DAS N-DO® INIETTORE, MITO-IN®, CT-DAS®/500 Ag-95, MINIPHYSIONIZER® 2.0 SMT, CT-DAS®/500 AG.

Among these devices, 5 are declared sterile, 4 active.

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 EUDAMED10
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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