EU → North America Device Access

Bio-Optica Milano S.p.A.

IT-MF-000027525 · Italy · Milano

Bio-Optica Milano S.p.A. is registered in the European database on medical devices as a manufacturer, with 453 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Most frequent device types declared: Accessories for pathology tests, Biomarkers, solvents, alcohols and paraffin for histology, Embedding cassettes for histology for printers, Fixatives for histology, Fixatives, decalcifiers, formalin prefilled.

Devices declared under this manufacturer

Showing 12 of 453 declared devices.

Catalogue references include 04-052812, 05-11007/L, 05-M03004, 07-7291, 07-MP2424, 10-42.

European nomenclature codes declared: W01030799, W01030708, W01030705, W05030501, W02070302, W05030599.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryBIO-OPTICA MILANO SPA (IT) · FDA 3003313105
Devices in EUDAMED453
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN453
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.

Other manufacturers in Italy

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