EU → North America Device Access

EB2C Srl

IT-MF-000019583 · Italy · Milano

EB2C Srl is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: AQ.OA-0045, AQBAS01, AQPRO01.

Among these devices, 3 are declared sterile, 7 active.

Devices declared under this manufacturer

Catalogue references include AQ.OA-0045, AQ.OA-OS0039, AQ.OA-PR0040, AQBAS01, AQNOS06, AQNOS08.

European nomenclature codes declared: Q019003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. EB2C Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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