EU → North America Device Access

Rücken sp. z o.o.

PL-MF-000025863 · Poland · Solec Kujawski

Rücken sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 107 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa107

Most frequent device types declared: HYDRO 3D, HYDRO MAX, TRAVEL SANITIZED.

Devices declared under this manufacturer

Showing 12 of 107 declared devices.

Catalogue references include 000116, 000128, 000867, 000873, 000891, 000900.

European nomenclature codes declared: V0899, T030502, V080302.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED107
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 GTIN107
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. Rücken sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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