Biosafe receives official registration of single use disposable kits with Chinese FDA

Apr 8 2014

Biosafe is proud to report that it has just received the official registration of its single use disposable kits with the Chinese FDA. Following earlier approval of the Company's Sepax cell processing machine, Biosafe is now primed to launch sales of its products in the People's Republic of China.

Olivier Waridel, CEO of the Biosafe Group commented: "We are the only company in our field which has received CFDA approval for both its equipment and kits. We are now eager to offer our industry-leading products throughout the People's Republic of China, having set up a Shanghai-based subsidiary in 2012 already. We have been in contact  with a number of major Chinese companies and institutions, which will now be able to access our state of the art technology.  We see tremendous potential both in the cord blood banking and regenerative medicine markets".

Biosafe's Sepax device, used in conjunction with its proprietary single use disposable kits,   offers a wide range of applications in cord blood banking and in the rapidly developing regenerative medicine area. It is used in a point of care environment such as cardiovascular and orthopedic, while in biotechnology and pharmaceutical processes it provides a versatile cell processing platform. Biosafe also offers a range of complementary products, such as the recently launched Smart-Max, for the preparation of cellular products.