EU → North America 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 IIa3 096
Class IIb3 146
Class I9

Most frequent device types declared: 0006, DENTAL IMPLANT, DENTAL IMPLANT, DENTALIMPLANT, Dental Implant.

Among these devices, 3 550 are declared sterile, 2 306 implantable, 307 reusable, 4 active.

Devices declared under this manufacturer

Showing 12 of 6 251 declared devices.

Catalogue references include A-PADE-AD330-30, A-ZT-330-220\t, L-CAMTABU-425-05, LS-M-425LN -120, SH-M-500SL-115\t, VSR-CAMCABUF-10.

European nomenclature codes declared: P010299, P01020101, L159099, Q010199, H010201020101, Q010207.

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

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. SWEDEN & MARTINA S.P.A. is registered in the United States but was not found in the Canadian register.

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