EU → US Device Access

S.A.L.F. S.p.A. Laboratorio Farmacologico

IT-MF-000010720 · Italy · Cenate Sotto

S.A.L.F. S.p.A. Laboratorio Farmacologico is registered in the European database on medical devices as a manufacturer, with 277 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I117
Class IIa87
Class IIb73

Most frequent device types declared: Auvita, Oculade, Articulade, Dentaheed.

Among these devices, 272 are declared sterile, 102 implantable.

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 registerNot found in the FDA register
Devices in EUDAMED277
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
EPT 0477.MDR.23/5217.1reissued2027-08-03
EPT 0477.MDR.23/5216.1reissued2027-08-03
CVD005526issued2028-01-19
CVD005426issued2028-01-19
CVD00240124issued2028-01-19
CVD0016230123issued2028-01-19
CVD000823issued2028-01-19
CVD0002230623supplemented2028-01-19

Other manufacturers in Italy

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