EU → US Device Access

H.S. Hospital Service S.p.A.

IT-MF-000026770 · Italy · Roma

H.S. Hospital Service S.p.A. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb4
Class IIa2

Among these devices, 4 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 registerRegistered with FDA
Matched entryH.S. HOSPITAL SERVICE S.P.A. (IT) · FDA 8010312
Devices in EUDAMED6
Country of registrationItaly

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