EU → North America Device Access

Villa Sistemi Medicali S.p.A.

IT-MF-000016860 · Italy · Buccinasco

Villa Sistemi Medicali S.p.A. is registered in the European database on medical devices as a manufacturer, with 157 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa101
Class IIb56

Most frequent device types declared: Chronos, Moviplan 800.

Among these devices, 157 are declared active.

Devices declared under this manufacturer

Showing 12 of 157 declared devices.

Catalogue references include 9771100803, 9784NB0213, 9787S0211A, 9788000100, 9788143200, 9788163200.

European nomenclature codes declared: Z11030506, Z11030503, Z11030702, Z11030501, Z11030701, Z11039015.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVILLA SISTEMI MEDICALI S.P.A. (IT) · FDA 8021091
Devices in EUDAMED157
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN157
Found in the U.S. device database4
Share2.5 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryVILLA SISTEMI MEDICALI S.P.A.

North American profile: Both markets. Villa Sistemi Medicali S.p.A. is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
049/MDRissued2027-10-04

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