Recently, Sanxin Medical extracorporeal circulation pipeline through the United States Food and Drug Administration (FDA) marketing authorization (K202796), this is the first sanxin medical blood purification series products obtained FDA marketing authorization (510K)!It is the fifth product to obtain FDA (510K) marketing authorization after the company’s safety syringe, disposable sterile syringe, IV catheter and medical mask.Sanxin Medical has also become the first manufacturer of extracorporeal circulation lines in China to obtain FDA (510K) marketing authorization, which covers multiple treatment modes of blood purification (hemodialysis, hemofiltration, hemodiafiltration, hemoperfusion, etc.). Currently, there are less than 20 manufacturers of extracorporeal circulation lines worldwide that have obtained FDA marketing authorization.

Founded in 1997, Sanxin Medical is a national high-tech enterprise specializing in the research, development, manufacturing, sales and service of medical devices. After 20 years of development, Sanxin Medical has grown into a leading supplier of complete hemodialysis consumables solutions in China. It is the first in the industry to pass the CE CMD quality management system and product certification.The successful approval of FDA(510K) marks that the hemodialysis pipeline products of Sanxin Medical are on par with the first-class level in the world, and it is also a strong witness that the Chinese brand has gained international market access and recognition. Sanxin Medical has opened a new era of global market competition.

Sanxin Medical will take this opportunity to continuously accelerate the strategic development pattern of independent domestic research and development and global synchronous development, shoulder the mission of national medical equipment brand development, promote more high-quality products to the world, provide patients with safe and high-quality products and services, and contribute to the development of global medical and health cause.