EU → North America 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

Most frequent device types declared: LAB40, MB200, Mikroskop Biologiczny OPTA-TECH serii LAB 50, Mikroskop Odwrócony OPTA-TECH serii MW 50, Ostrze do trymowania 130 mm PathoEdge.

Devices declared under this manufacturer

Showing 12 of 33 declared devices.

Catalogue references include LAB 50, LAB40 MULTI, MB200 LCD, MW50 FL, OT.MSGE45L.G, PE-130.

European nomenclature codes declared: W0202050303, W0202059085, W0503900201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED33
Country of registrationPoland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN33
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. OPTA-TECH Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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