EU → North America Device Access

HYDREX DIAGNOSTICS Sp. z o. o.

PL-MF-000010271 · Poland · Warszawa

HYDREX DIAGNOSTICS Sp. z o. o. 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

Most frequent device types declared: Manualplate 5, Manualplate 6, Manualplate 7, Manualplate 9, Manualplat.

Devices declared under this manufacturer

Catalogue references include 90225, 90226, 90227, 90229, 90232.

European nomenclature codes declared: W05039080.

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. HYDREX DIAGNOSTICS Sp. z o. o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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