EU → US Device Access

SYNTESYS S.R.L.

IT-MF-000027856 · Italy · TEOLO (PD)

SYNTESYS S.R.L. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24
other8

Most frequent device types declared: Urinale in plastica, Padella in plastica per pazienti allettati, Contenitori per la raccolta di campioni di urina, 331225, 380201: Tamponi secchi asta in plastica, punta in viscosa, in provetta.

Among these devices, 9 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 EUDAMED32
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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