EU → North America Device Access

NUOVA BN SRL

IT-MF-000016004 · Italy · TO

NUOVA BN SRL is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: 1010 Series, 2010 Series, 3010 Series, BN 93 Series, BN ETP Series.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include 1010/5, BN 93, BN ETP, BN ETP EL CS, EM 00 MODULO, EM 2010/5 S BP.

European nomenclature codes declared: Z12011202, Z11030503.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. NUOVA BN SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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