EU → North America Device Access

Andrzej Bugajski ,,DALPEX" Przedsiębiorstwo Produkcyjno-Handlowe

PL-MF-000036903 · Poland · Wrocław

Andrzej Bugajski ,,DALPEX" Przedsiębiorstwo Produkcyjno-Handlowe is registered in the European database on medical devices as a manufacturer, with 72 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa72

Most frequent device types declared: 0,25m²; 0,5m²; 1m², 0,5 m2, 4m x 5cm; 4m x 10cm; 4m x 15cm, 5x5 cm (5 szt.), 5x5 cm; 7,5x7,5 cm; 10x10 cm.

Among these devices, 13 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 72 declared devices.

Catalogue references include BUSS_APTEO_S, GAZA_J_0,5_NURSEA, GAZA_NJ_1_CEP, OPD_4x5_3MMM, OPET_5x10_APTEO, OPET_5x8_3MMM.

European nomenclature codes declared: M04010102, M03040199, M0201020102, M0201050101, M03040299, M0202030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED72
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 GTIN72
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. Andrzej Bugajski ,,DALPEX" Przedsiębiorstwo Produkcyjno-Handlowe was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →