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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: R-100, Z-100.2.0.P AGA, Z-100.2.0.P DIN, Z-100.2.1.P, Z-100.2.2.P.

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

Devices declared under this manufacturer

Catalogue references include R-100, Z-100.2.0.P, Z-100.2.0.PD, Z-100.2.1.P, Z-100.2.2.P.

European nomenclature codes declared: Z120309.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. MetalERG Spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.

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