EU → North America Device Access

K S P Italia S.r.l.

IT-MF-000009316 · Italy · BEVAGNA

K S P Italia S.r.l. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24

Most frequent device types declared: K05-2R, N33, N716/170, SPONDE UNIVERSALI.

Among these devices, 18 are declared active.

Devices declared under this manufacturer

Showing 12 of 24 declared devices.

Catalogue references include A9121C, K05-2R, K801-2R 08PE, K801-2R 08SE, K810-2R 08PE, K810-2R 08RO.

European nomenclature codes declared: Y180918, V08068001, Y091203, V0805030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED24
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN24
Found in the U.S. device database0
Share0.0 %

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: Neither register. K S P Italia S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →