EU → US Device Access

SWEDEN & MARTINA S.P.A.

IT-MF-000007391 · Italy · Due Carrare

SWEDEN & MARTINA S.P.A. is registered in the European database on medical devices as a manufacturer, with 6 251 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb3 146
Class IIa3 096
Class I9

Most frequent device types declared: Prosthetic Component, DENTAL IMPLANT , Surgical Instrument, DENTAL IMPLANT, 0006.

Among these devices, 3 550 are declared sterile, 2 306 implantable, 307 reusable, 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 entrySWEDEN & MARTINA S.P.A. (IT) · FDA 3001082453
Devices in EUDAMED6 251
Country of registrationItaly

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