The Cerkamed company has a Quality Management System meeting the requirements of the norm EN ISO 13485:2016 in relation to design, manufacture and distribution of medical devices for dentistry.
Our products have the declarations of conformity with the medical directive MDD 93/42/EEC.
According to the Regulation (EU) 2023/607 as regards the transitional provisions for certain medical devices certificates issued by notified bodies in accordance with the directive 93/42/EEC that were still valid on 26.05.2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the date 31.12.2028 for IIa class devices. PPH CERKAMED meets the requirements of the regulation, therefore certificate no. 144731-18-02-18 is valid.
