Carbonhand 2.0 approved as a medical device according to the EU-MDR
For people with impaired hand function, a new aid is now coming onto the market. The grip-strengthening glove Carbonhand® from Bioservo is now classified and approved as a medical device according to the European Medical Device Regulation (EU-MDR), which means that Carbonhand 2.0 can go on sale in Europe.[Vattna blommor med Carbonhand]
After intensive development work, as well as passing safety tests carried out by an independent test house, Carbonhand 2.0 is now approved as a medical technical assistive device according to current regulations in Europe. In order to obtain this approval,