Press release from Companies
Publicerat: 2021-06-16 08:30:00
The VibroSense Meter® II system (VSM II) is registered to comply with the new EU Medical Device Regulation (MDR) as a class 1 Medical device. A registration is made at the Swedish Medicines Agency where VibroSense Dynamics has received the EUDAMED registration number (SRN) SE-MF-000003787. Thus, the VibroSense Meter® II system has now a CE-mark which complies with the new MDR which became mandatory within the EU since May 26, 2021.
After extensive work, VibroSense fulfills all requirements for CE marking of VibroSense Meter® II according to the MDR. This includes everything from ensuring that the instrument meets required standards for patient safety as well as safety for operating personnel, to that the instrument works according to the declared intended purpose. Contact Hans Wallin, CEO VibroSense Dynamics AB, www.vibrosense.com About VibroSense Dynamics AB (publ) VibroSense Dynamics AB (public) develops and markets efficient systems to support early detection and diagnosis of sensory neuropathy, i.e. disease of large nerve fibres and nerve trunks in e.g. legs and arms. The Company, founded in 2005, has been listed on Spotlight stock market since May 2015.
Phone: +46 40 88 026
E-mail: info@vibrosense.com