STANCHY ® AH Successfully Passed ISO 13485
Recently, Absorbable Hemostat-STANCHY ® of our Lucktin Biotech has passed ISO 13485 Medical Device Quality Management System Certification.
STANCHY ® is an absorbable hemostat, which is easy to operate and can stop bleeding quickly and effectively. It can be used for auxiliary hemostasis in the wound bleeding area of various trauma and surgery fresh tissues. The product is an intraoperative hemostatic material which was originally developed by Medafor, a US-based company affiliated to CR Bard, and marketed as Arista TM AH (Absorbable Hemostat）which has been approved in Europe in August 2002 and approved in US in September 2006. Now the sales have reached all corners of the world.
Considering the tension of blood source and risk of blood transfusion, STANCHY ® as an intraoperative hemostatic product, can reduce blood loss and transfusion need in surgery, reduce the risk of transfusion infection, and more conducive to patient recovery.
Now, STANCHY ® is in the stage of CE certification. If approved for marketing, STANCHY ® will add another good quality product to the Maxmind product line and better cater to the needs of clinicians.