EU → US Device Access

STERIS Italy S.r.l.

IT-MF-000007606 · Italy · Pomezia

STERIS Italy S.r.l. is registered in the European database on medical devices as a manufacturer, with 166 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa145
Class IIb21

Most frequent device types declared: RAPIDAER Endoscope Reprocessor Hookups, Storage cabinet with drying functions, Cold Chemical Sterilant, Neutra Flush, Proteazone.

Among these devices, 2 are declared sterile, 31 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 registerRegistered with FDA
Matched entrySTERIS Italy S.r.l. (IT) · FDA 3012708860
Devices in EUDAMED166
Country of registrationItaly

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