Xenios A6, a Fresenius Medical Care company, has received approval from the National Medical Products Administration (NMPA) in China for the Xenios console and patient kits for ECMO therapy.
In early May, Xenios AG, a Fresenius Medical Care company, received approval for two patient kits in China. It follows NMPA's approval of the Xenios console back in December 2020. As a result, a complete Xenios system is now permitted for ECMO therapy in China.
Xenios received the approval through a process called "Fast Registration". This expedited process is only offered for products that, for example, are urgently needed for clinical use and can treat serious, life-threatening diseases. This Xenios ECMO complete system is certified in China for nine days application period. It is also the first ever "Fast Registration" for new imported medical devices in China.
"We are particularly proud to have received this approval!" says Jörg Buschbell, CEO of Xenios AG, and adds, "In just over a year, we have gained access not only to the US market, but also to the Chinese market for our ECMO therapy products. This marks another milestone for Xenios AG and Fresenius Medical Care."
The expedited approval was a joint effort by Xenios and Fresenius Medical Care China Team. Since the beginning of the pandemic, they strived to make our advance critical care products available in china for treating the criticaly ill patients, "says Harry De Witt, President and CEO of Fresenius Medical Care Asia Pacific. "The approval means that we will be able to support the chinese critical care community further with our advance developments, ultimately benfeting the patients." |
