Certifications create trust!

gym80 is a certified medical device manufacturer of the MED80 series.

Our quality management system is certified by TÜV Hessen according to EN ISO 13485.

This means that we communicate our high quality standards and also meet the requirements of the European Medical Device Regulation EU 2017/745 (MDR) for our MED80 products throughout their entire life cycle.

Through the CE marking and declaration of conformity of our MED80 products, we confirm compliance with the general safety and performance requirements (GSPR) of the EU MDR.