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 IIa | 72 |
|---|
Most frequent device types declared: 5x5 cm; 7,5x7,5 cm; 10x10 cm, 4m x 5cm; 4m x 10cm; 4m x 15cm, Staw: kolanowy, skokowy, nadgarstkowy, 0,25m²; 0,5m²; 1m² , 0,5 m2.
Among these devices, 13 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 72 |
| Country of registration | Poland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.