CERKAMED has a quality management system in accordance with EN ISO 13485:2016 within the scope of design, production and distribution of medical devices for dentistry.
CERKAMED has obtained a certificate of conformity with Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR) for devices covered by MDN code 1202.*
*MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
Other medical devices have a certificate of compliance with the medical directive MDD 93/42/EEC.
CERKAMED meets the requirements of Regulation (EU) 2023/607, and therefore certificate no. 144731-18-02-18 remains valid no longer than 31.12.2028.
