EU → North America Device Access

Biochemical Systems International S.p.A.

IT-MF-000028905 · Italy · Milano

Biochemical Systems International S.p.A. is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: Aria Blood Glucose Meter, Aria Control Solution, Aria Glucose Test Strips, MulticareIN Cholesterol Test Strips, MulticareIN Glucose Control Solution.

Devices declared under this manufacturer

Showing 12 of 52 declared devices.

Catalogue references include 3830003IT, 3830261HU, 3830270, 3830271SP, 3830300, 3880001V.

European nomenclature codes declared: W0101060101, W0201060102, W01010805, W0101060105, W0101060102, W010106010801.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED52
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 GTIN52
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryBIOCHEMICAL SYSTEMS INTERNATIONAL S.R.L.

⚠️ A similar name exists; unverified — why.

Other manufacturers in Italy

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