EU → North America Device Access

"DANLAB" Danuta Katryńska

PL-MF-000049935 · Poland · Białystok

"DANLAB" Danuta Katryńska is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa64

Catalogue references include MED_010_2D_WS, MED_011_1D_WP, MED_012_1_SWO, MED_013_1_SZWO_C, MED_014_1D_SZW_N, MED_015_2D_SZW_N.

European nomenclature codes declared: V0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED64
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 GTIN64
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. "DANLAB" Danuta Katryńska was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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