On October 31, according to the information released on the official website of the Medical Device Technology Evaluation Center of the State Food and Drug Administration, the Wynca Tinyo XHG-6920 series and Wynca Tinyo TYE771 series  silicone rubber materials produced by Wynca Tinyo silicone Co., Ltd. (hereinafter referred to as "Wynca Tinyo"), a wholly-owned subsidiary of Wynca Group, were successfully reviewed by the Medical Device Evaluation Center of the State Food and Drug Administration of China, and were registered by the main documents of medical devices.

  Wynca Tinyo TYE771 series is mainly catalyzed by platinum. The product has also obtained the biocompatibility certification of ISO 10993 series and USP 88 Class VI. It has good mechanical performance and excellent shaping, and is suitable for the manufacture of various medical catheters and medical molded parts.

  In order to comprehensively improve the service capability of medical device, Wynca Tinyo established a professional team for the medical and health care in 2018. Relying on the advantages of the complete industry chain, it continuously improves and optimizes product categories every year to create solutions for the medical and health care industry. At present, it has established close cooperation with a number of domestic   well-known medical device listed companies and foreign well-known medical device groups. In 2020, it successfully obtained the ISO13485 medical device quality management system certification, and its service scope includes the design and production of silicone materials for medical devices.

  This time, the silicone rubber registration of the National medical device master file has provided a strong guarantee for Wynca Tinyo to further expand high-standard international markets such as Europe and the United States. It also provides important benefits for deepening the cooperation with large domestic and foreign enterprises, entering the special terminal application, and replacing the specific import products.