10MD receives CE mark approval

Jan 25, 2018

10MD gains market access for HeadPeace with the CE mark approval from the notified body. 

HeadPeace is a radiation protection device based on SafeTex, a patented textile platform, and was developed to minimize cranial exposure of 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 informing 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 - SafeTex. SafeTex is patented and constitutes of a breathable woven fabric 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.    

 

 

For further information, please contact Petra Apell, founding partner, +46 705 735262, petra.apell@10md.se

 

* NAFT is a trademark of Ten Medical Design AB.

__________________________________________________________________________________

 

Ten Medical Design AB
Corporate identity number 556890-3099
Website: www.10md.se