Suokang Got CE Mark
Online, March 25, 2011 (Newswire.com)
-
Shanghai Suokang Medical Implants Co., Ltd., the only one legal site which specializes in manufacturing the expanded Polytetrafluoroethylene e-PTFE in medical implantation over the People's Republic of China, has announced European CE Mark approval of its Tisuthes® Surgical Patch, a soft tissue augmentation product which is using in Cosmetic and Plastic surgical field, after receiving clearance from the State Food and Drug Administration China (SFDA) and Korean Food and Drug Administration Korea (KFDA).
Leo Ye CEO & President of Shanghai Suokang Medical Implants commented:
"After Tisuthes® Surgical Patch cleared by SFDA and KFDA, gaining CE mark is another key milestone for Shanghai Suokang Medical Implants in its drive to become one of the leading international suppliers of innovative devices for use in Plastic and Cosmetic surgical procedures. We are confident that the Tisuthes® Surgical Patch will enhance the range of permanent implant standard to an even higher level.
"Achieving this CE mark is significant step in our sales and marketing plan for FY2011, as this product can now be distributed in European market, one of the largest in the world Plastic and Cosmetic surgical device".
About Tisuthes Surgical Patch
Tisuthes® surgical patch, the original technology from e-PTFE vascular graft, according to its biological inert, has been used in humans as an implantable material for more than 24 years in China. The device is designed to restore soft tissue defect and/or deformation. Compared with silicon prosthesis, e-PTFE allows body tissue in growth inside the implants node and fiber structure, which means e-PTFE becomes a real body part. China has long history of producing e-PTFE vascular graft back from 1985 and Shanghai Suokang Medical Implant Co., Ltd. has extended the vascular graft technology to the soft tissue augmentation market. After the launch Tisuthes™ surgical patch in China from Jan, 2005. The product safety and effectiveness has been demonstrated through more than 9 years over 100,000 clinical applications of Suokang medical implants. It sharply draws all the attentions in plastic and constructive surgical field in pacing with its unquestionable success. Right now, Tisuthes® surgical patch is one of the top priority choices implant material over China with its solid reputation.
About Shanghai Suokang Medical Implants Co., Ltd
Shanghai Suokang Medical Implants Co., Ltd. is the only one legal factory which has been innovator and leading designer in manufacturing e-PTFE for medical implant over the People's Republic of China. Suokang strictly implement quality management systems: ISO 9001 and ISO 13485. The quality objective of Suokang: Creative, Critical, Cohesive and Customize (4C) further drive high quality product output. Our products including Tisuthes® Surgical Patch, Hemothes® vascular graft, and Membthes® surgical membrane are designed at Aesthetic surgery, Plastic surgery, Vascular surgery, Neurosurgery, Orthopedic surgery, Cardiac surgery and General surgery. With headquarter in Pudong, Shanghai, the People's Republic of China.