EU → US Device Access

OSCAR BOSCAROL SRL

IT-MF-000007810 · Italy · BOLZANO

OSCAR BOSCAROL SRL is registered in the European database on medical devices as a manufacturer, with 229 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa133
Class IIb96

Most frequent device types declared: OXIKIT PLUS, OB2012, OB1000, OB3000, OB MINI.

Among these devices, 202 are declared 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 registerNot found in the FDA register
Devices in EUDAMED229
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
ITH 1281809 1supplemented2027-11-21

Other manufacturers in Italy

All Italy manufacturers →