EU → North America Device Access

Metalowiec Sp. z o.o.

PL-MF-000048082 · Poland · Namysłów

Metalowiec Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa82

Most frequent device types declared: Barierki boczne łóżkowe składane, Ramka na kartę chorobową, Stolik oddziałowy zabiegowy S0-1, Stół rehabilitacyjny do masażu suchego Standard SR-01, Szafka przyłóżkowa metalowa bez regulacji SM-01.

Among these devices, 20 are declared active.

Devices declared under this manufacturer

Showing 12 of 82 declared devices.

Catalogue references include MET-AKS-BAR.NAKŁADKA, MET-AKS-BAR.UNIWER, MET-AKS-KOSZ.TLEN, MET-LOZ-A4.drew, MET-LOZ-ANDIMED, MET-SZAF.SP04.

European nomenclature codes declared: V080602, V08068099, V0899, V0806010701, V08060101, V08068001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED82
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 GTIN82
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. Metalowiec Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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