10MD gains market access for HeadPeace with the CE mark approval from the Notified Body.
HeadPeace is a radiation protection device based on TeXray, a patented textile platform, and was developed to minimize cranial exposure to ionizing radiation. The CE mark declares that HeadPeace meets the essential requirements of the PPE Directive (89/686/EEC), outlining the safety and performance requirements for personal protection equipment (PPE). The CE mark is a legal requirement for access to the European market.
"It is a pleasure to inform customers and share-holders that 10MD has received its first CE mark approval from SGS, the Notified Body for PPE. We are now ready to introduce HeadPeace to European healthcare professionals," says Fredrik Gellerstedt, CEO at 10MD.
10MD has developed the first radiation protection textile - TeXray. TeXray is patented and constitutes of a breathable textile that protects the user from harmful radiation during surgical interventions. HeadPeace is the company´s first product and was recently clinically validated by end users in Sweden.