EU → US 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

other453

Most frequent device types declared: Staining kit, solvents and reagents for pathological anatomy, Biomarkers, solvents, alcohols and paraffin for histology, Staining solution for tissue sections, Fixatives, decalcifiers, formalin prefilled, Fixatives for histology.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

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 in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Italy

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