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 market presence in Southeast Asia and serving global clinical and research users [1] Group 1: Product Development and Approval - The BioCyte series flow cytometers were developed by the company's subsidiary, Zhongsheng (Suzhou) Medical Technology Co., Ltd [1] - The registration number for the medical device is IVDA9463526–225393, indicating compliance with Malaysian regulatory standards [1] - The approval signifies that the product is now eligible for legal marketing, sales, and use in Malaysia [1] Group 2: Market Implications - The 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] - The company will collaborate with local authorized representative TRUSTDIAGNOSTICS SDN BHD to advance its market strategy in Malaysia [1]
中生北控生物科技(08247.HK)附属中生(苏州)医疗科技产品获发马来西亚医疗器械注册证