EU → North America Device Access

CYANAGEN Srl

IT-MF-000038227 · Italy · Bologna

CYANAGEN Srl is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: STAR BEADS GENOMIC DNA EXTRACTION KIT, STAR BEADS PATHOGEN DNA/RNA EXTRACTION KIT.

Devices declared under this manufacturer

Catalogue references include SBK247,1X96PFI, SBK261,2X32PFI, SBK265,1X10, SBK265,1X96, SBK287,1X96PFI.

European nomenclature codes declared: W010699, W0105900101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. CYANAGEN Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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