Arkona
Niemce, Poland
Polish producer of dental materials and products, on the market since 1995 with three production plants.
Business types in Niemce
Regulation in Poland
Poland is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Poland · All medical certifications
Frequently asked questions
How are Polish instrument companies spread across city pages?
Polish listings are spread thinly: the directory currently has city pages for Warsaw, Łódź, Bydgoszcz and Rudniki with a couple of companies each, and other Polish companies appear only on the country page. Searching city by city can miss suppliers, so start from the Poland country page and use the role filter for distributors or manufacturers to narrow the list.
Because many Polish companies act as distributors of foreign brands, ask each one for the legal manufacturer's name, the EU Declaration of Conformity and, for non-EU brands, the EU authorized representative.