EU → North America Device Access

BIOLINK S.R.L.

IT-MF-000055108 · Italy · Napoli

BIOLINK S.R.L. 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

Devices declared under this manufacturer

Catalogue references include BL-CAM-EV, BL-GIT1010, BL-GIT2020, BL-GIT3030, BL-GIT4040, BL-GIT5050.

European nomenclature codes declared: M0201010102, T0205, A06030301.

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. BIOLINK S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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