EU → North America Device Access

Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.

PL-MF-000038261 · Poland · Gliwice

Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 168 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa168

Most frequent device types declared: 1114, ALMAGRO, Alfa / Gamma / Sigma, MAGELLAN, Mobilux.

Among these devices, 1 are declared reusable, 154 active.

Devices declared under this manufacturer

Showing 12 of 168 declared devices.

Catalogue references include 01401204, 01501210, 01501401, 01501420, 14501102, 14501206.

European nomenclature codes declared: Z120618, Z120602, Y0599, Z120603, Z120616, Z12062499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED168
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 GTIN168
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. Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o. was not found in either the U.S. or the Canadian register.

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