EU → North America 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: OB MINI, OB1000, OB2012, OB3000, OB500.

Among these devices, 202 are declared active.

Devices declared under this manufacturer

Showing 12 of 229 declared devices.

Catalogue references include 11022/FA, BSU150ID, BSU3002JP, BSU3023A, OXIP2649, OXIP3320.

European nomenclature codes declared: Z120105, R02010101, V0899, V080504, M030599, V0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED229
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN229
Found in the U.S. device database0
Share0.0 %

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: Neither register. OSCAR BOSCAROL SRL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 1281809 1supplemented2027-11-21

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