EU → US Device Access

OPTA-TECH Sp. z o.o.

PL-MF-000050182 · Poland · Warszawa

OPTA-TECH Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other33

Most frequent device types declared: MB200, LAB40, Mikroskop Biologiczny OPTA-TECH serii LAB 50, Mikroskop Odwrócony OPTA-TECH serii MW 50, Ostrze do trymowania 260 mm PathoEdge 260.

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 registerNot found in the FDA register
Devices in EUDAMED33
Country of registrationPoland
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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