Quality

Mitsar. Co. Ltd. quality management system

Quality system

Mitsar. Co. Ltd. quality management system is certified to be in compliance with the International standard for medical devices ISO 13485:2016.

Mitsar products have been classified as Class IIa devices and are in conformity with requirements of Annex I of the European council directive 93/42/EEC and are CE marked under the supervision of Notified Body Eurofins Expert Services Ltd.

Certificates for download

Declarations of Conformity