We are digital
All Information at a Glance
In our digital download area, you will find all important documents related to our products and services – clearly organized and available anytime.
Instructions for use
Instructions for use
Certifications Build Trust
gym80 is a certified medical device manufacturer for the MED80 series.
Our quality management system is certified by TÜV Hessen according to EN ISO 13485.
Through this, 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 lifecycle.
With the CE marking and Declaration of Conformity for our MED80 products, we confirm compliance with the general safety and performance requirements (GSPR) of the EU MDR.