EU → US Device Access

MetalERG Spółka z ograniczoną odpowiedzialnością

PL-MF-000034757 · Poland · Oława

MetalERG Spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb5

Most frequent device types declared: Z-100.2.0.P AGA, Z-100.2.2.P, R-100, Z-100.2.1.P, Z-100.2.0.P DIN.

Among these devices, 5 are declared with a measuring function.

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 EUDAMED5
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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