Shinva Medical Instrument Co Ltd

Shinva Medical Instrument announced that its respiratory gating system has received a Class III medical device registration certificate from the National Medical Products Administration. The system is used to collect patient respiratory pattern information to coordinate with CT equipment for acquiring synchronized images and monitoring position. Its thoracoscopic surgical instruments have received a Class II medical device registration certificate from the Shandong Provincial Medical Products Administration. The instruments consist of vascular forceps, tissue forceps, needle holders, thoracic scissors, and other components, and are used in conjunction with thoracoscopes. The company stated that the two products will respectively create synergy with its existing large-bore CT positioning equipment and endoscopic camera systems, strengthening its competitiveness in precision radiotherapy and minimally invasive endoscopic surgery.

Xinhua Surgical Instruments, a subsidiary of Xinhua Medical, recently obtained a Class III medical device registration certificate issued by the National Medical Products Administration for its disposable plasma surgical electrode. The certificate was approved on August 17, 2026, and is valid until August 16, 2031. The product is used with plasma surgical equipment in a saline environment for cutting and coagulating soft tissue in the ear, nose, and throat during open or endoscopic surgery, offering advantages such as low-temperature cutting, minimal thermal damage, and precise bipolar structure.

Xinhua Medical announced that its board of directors has approved a proposal for its wholly owned subsidiary Huatuo International to invest 80 million yuan to establish Xinhua Platinum Vision Endoscopy Shanghai Co., Ltd., with a registered capital of 80 million yuan. The main business will be the production and distribution of Class II and Class III medical devices. Xinhua Medical stated that Xinhua Endoscopy will focus on specialized fields such as gastroenterology, respiratory, and urology, and through the research and innovation of high-end medical devices like flexible endoscopes, it will drive the company's product upgrade from basic support to precision diagnosis and treatment.

Xinhua Medical announced that the company recently received a Class III medical device registration certificate from the National Medical Products Administration for its fully automatic blood typing analyzer, and a Class II medical device registration certificate from the Shandong Medical Products Administration for its vertical steam sterilizer. The fully automatic blood typing analyzer uses the column agglutination method for ABO blood grouping, RhD blood grouping, irregular antibody screening, and cross-matching tests. The vertical steam sterilizer employs gravity displacement and positive pressure pulsation cold air removal methods for sterilizing moisture- and heat-resistant medical devices.

Shinva Medical Instrument announced that the company and its subsidiary Shinva Surgical Instruments have recently obtained multiple medical device registration certificates issued by the Shandong Medical Products Administration and the National Medical Products Administration. Among them, the disposable plasma surgical electrode received a Class III registration certificate, to be used with plasma surgical equipment for joint soft tissue cutting and coagulation. The hysteroscope, large benchtop steam sterilizer, flexible endoscope washer-disinfector, and multi-functional cleaning and disinfection center received Class II registration certificates, respectively used for gynecological uterine cavity examination and minimally invasive treatment, sterilization of moisture- and heat-resistant medical devices, second-generation isolated washing and disinfection, and integration of six functional units. The company stated that the approval of the above products will improve the product matrix in the fields of minimally invasive surgery and infection control, enhancing comprehensive competitiveness, but actual sales depend on market promotion effectiveness, and the specific impact on performance cannot be predicted at this time.

Xinhua Medical announced that the company and its subsidiary Xinhua Surgical Instruments have recently obtained the Medical Device Registration Certificate of the People's Republic of China issued by the Shandong Medical Products Administration. The company's self-developed mobile C-arm X-ray machine, including four models such as the MDC660i, is suitable for surgical fluoroscopy and radiography, while the subsidiary Xinhua Surgical Instruments' urethrocystoscope is suitable for examination and surgery of diseases in the urethra or bladder.