EU → North America Device Access

Senpo Sp. z o.o. Sp.k.

PL-MF-000049973 · Poland · POGÓRZE

Senpo Sp. z o.o. Sp.k. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Materac medyczny przeciwodleżynowy.

Devices declared under this manufacturer

Catalogue references include MATHI003016, MATHI299187, MATHI335980, MATHI388968, MATHI451778, MATHI543099.

European nomenclature codes declared: V080702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. Senpo Sp. z o.o. Sp.k. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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