EU → North America 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.

Devices declared under this manufacturer

Catalogue references include APK14150T19V5, APK16270T19V5, BMSOFT, CITO 100, INF06012-5, RF17100E05V1.

European nomenclature codes declared: Z1204021580, A0280, K02030101, A05010101.

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

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database2
Share33.3 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. H.S. Hospital Service S.p.A. is registered in the United States but was not found in the Canadian register.

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