万孚生物：自主研发的U-CardDx 200全自动核酸扩增分析仪获NMPA第三类医疗器械注册批准上市

Core Insights - Wanfu Bio has received NMPA Class III medical device registration approval for its self-developed U-CardDx 200 fully automated nucleic acid amplification analyzer, which has also obtained EU CE IVDR certification and is already in use in several overseas countries [2] Group 1 - The U-CardDx 200 significantly reduces the molecular testing process to just 15 minutes by utilizing classic magnetic bead nucleic acid extraction and real-time fluorescence quantitative PCR technology [2] - The device functions as a complete molecular diagnostic laboratory, capable of meeting routine testing needs as well as urgent testing demands during peak times [2] - The company plans to continuously expand its product offerings based on the U-CardDx 200 platform [2]