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abcMED spółka z ograniczoną odpowiedzialnością

PL-MF-000034816 · Poland · Kraków

abcMED spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: DP 050 Pneumotachograf dPP, Klips na nos, Oprogramowanie spirometrów diagnostycznych, Przewód pneumotachografu dPP 1.5 m, Spirometr diagnostyczny PNEUMO.

Among these devices, 5 are declared active, 2 with a measuring function.

Devices declared under this manufacturer

Catalogue references include DP 050, KN 051, PN 001, PP 020, PP 030, PS PNEUMO.

European nomenclature codes declared: Z12150199, R9001, Z12150192, Z12159008, Z12150101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. abcMED spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.

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