EU → North America Device Access

BIOGYN SRL

IT-MF-000033403 · Italy · MIRANDOLA

BIOGYN SRL is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Most frequent device types declared: APPLICATORI A TESTA GRANDE, TUBO SPIRALATO CM. 200.

Devices declared under this manufacturer

Catalogue references include EBR1 B25, EBR1 N25, SAF1 N120, SFA1 N120, SPI1 N20, SPI1 N25.

European nomenclature codes declared: K02010107, A1101, U09030301, V0299, U089002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
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 GTIN12
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. BIOGYN SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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