Confirmation of Distribution of Medical Devices
___
From the 5th of April 2021, our company becomes the holder of a Certificate of Distribution of Medical Technological Materials based on Directive 93/42/ΕΟΚ (which has been harmonized with the Directive ΚΥΑ ΔΥ8δ/Γ.Π.οικ.130648).
Our Company was evaluated by the National Evaluation Center of Quality and Technology in Health (EKAPTY SA) supervised by the Ministry of Health. EKAPTY operates as an independent Certification Operator of Quality Systems and Products. As an accredited operator, it evaluates and certifies quality systems of companies in accordance with the requirements of the standards ISO 9001: 2015 & ISO 13485: 2016 but also of the Ministerial Decision ΔΥ8 / 1348/04.
The specific operator evaluated the compliance of our Company for the distribution of medical devices in accordance with the requirements of Directive 93/42 / EEC (which has been harmonized with the KYA ΔΥ8δ / Γ.Π.οικ.130648). The Product Conformity Certificate issued by EKAPTY as well as the issuance of the CE 0653 marking means that the certified product is produced in such a way as to comply with the requirements of the applicable Legislation.
