9家国产仪器突围，2025流式细胞仪NMPA获证盘点

Core Insights - In 2025, a total of 10 flow cytometers received NMPA certification, with 9 being domestic brands, indicating a trend towards high-end, intelligent, and multi-parameter technology that supports clinical precision medicine [1][30]. Group 1: Industry Overview - Flow cytometry, developed in the 1970s, has evolved from basic research to clinical applications in disease diagnosis and treatment monitoring, with the first flow cytometer introduced in China in the early 1980s [2]. - Flow cytometers can measure cell size, internal particle characteristics, and detect surface and cytoplasmic antigens, as well as DNA and RNA content, allowing for rapid analysis of large cell populations [2]. Group 2: Certification and Product Highlights - In 2025, 10 flow cytometers were approved, including 9 domestic brands and 1 imported brand, with notable models such as Cl inStel lar AX from Chenglang Bio, which received certification in December [3][6]. - The Cl inStel lar AX is a high-end spectral flow cytometer that breaks the monopoly of imported brands in the high-end clinical field, providing cost-effective solutions for domestic medical institutions [6][30]. - The BioCy teX from Zhongsheng Medical is the first domestic 4-laser 21-color flow cytometer, marking a significant breakthrough in high-end flow cytometry capabilities [15][30]. Group 3: Technological Advancements - Prism Tech has achieved breakthroughs in PMT and APD detector technologies, creating a dual-platform system that enhances the technical breadth and application depth of domestic flow cytometers [7][30]. - Automation and intelligence upgrades are evident in devices like the Khroma series from Meiruite and EasyCell Plus from Weigong Technology, which feature high-throughput automatic sample loading systems [10][19][30]. Group 4: Market Trends and Future Outlook - The rapid increase in domestic brand certifications indicates a shift towards domestic alternatives and internationalization, with Zhongsheng Medical's BioCy te gaining registration in Indonesia, marking the beginning of overseas expansion for domestic manufacturers [31]. - The flow cytometry market is moving towards automation, intelligence, and multi-dimensional development, expanding applications from hematology to oncology, cell therapy, and infectious immunity [31].