浙江东方基因生物制品股份有限公司 关于自愿披露获得医疗器械注册证的公 告

Core Points - Zhejiang Oriental Gene Biological Products Co., Ltd. and its subsidiaries have recently obtained several medical device registration certificates, enhancing their product offerings in the respiratory infection detection market [1][2] - The approval of the influenza virus antigen detection kits will help the company address seasonal respiratory infections, while the certification of various antibody detection kits will expand the application of their flow cytometry technology platform [1] - The FDA approval of the fentanyl fluorescence immunoassay test kit marks the company's first FDA-approved fluorescence immunoassay product, which is expected to improve drug abuse detection accuracy in the U.S. market [2] Summary by Categories Domestic Medical Device Registration - The company has received registration certificates for influenza virus antigen detection kits, which will diversify its product range in the domestic respiratory infection detection market [1] International Medical Device Registration - The FDA approval of the fentanyl fluorescence immunoassay test kit is a significant milestone for the company, enhancing its presence in the U.S. market [2] Impact on the Company - The new certifications are expected to broaden the company's product offerings and support overall market expansion in China, particularly in the field of respiratory infections and drug abuse detection [1][2]