Core Viewpoint - The company has successfully obtained medical device registration for its BioCyte series flow cytometers in Malaysia, marking a significant step in expanding its presence in the Southeast Asian market [1] Group 1: Product Development and Approval - The BioCyte series flow cytometers developed by the company's subsidiary, China Bio (Suzhou) Medical Technology Co., Ltd., have passed the Malaysian Medical Device Authority's review [1] - The registration number for the medical device is IVDA9463526–225393, indicating that the product is now legally qualified for sale and use in Malaysia [1] Group 2: Market Expansion and Strategy - The approval allows the company to expand its market reach in Southeast Asia and enhance its brand influence and market coverage internationally [1] - The product will be marketed through the local authorized representative, TRUST DIAGNOSTICS SDN BHD, facilitating the company's market entry strategy [1] Group 3: Technology Application - Flow cytometry technology is widely used in clinical diagnostics and research, providing technical support for disease diagnosis, immunology research, and drug development [1] - The BioCyte series has already been applied in the domestic market due to its stable performance and accuracy in detection [1]
中生北控生物科技附属中生医疗自主研发的BioCyte 系列流式细胞仪获发马来西亚医疗器械注册证