Zhejiang Orient Gene Biotech Co.,Ltd. (688298.SH) Subsidiary Obtains Medical Device Registration Certificates

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Zhejiang Orient Gene Biotech Co.,Ltd. (688298.SH) announced that its wholly-owned subsidiary Healgen Scientific LLC (referred to as "American Healgen") and controlling subsidiary Hangzhou Laihe Biotechnology Co., Ltd. (referred to as "Laihe Bio") have recently obtained registration certificates for multiple medical device products. The company's respiratory combined detection reagents have obtained certifications in China, the EU, and Israel, further enriching and improving the company's respiratory joint detection product portfolio in these countries and regions, expanding the range of saleable product categories, and facilitating the detection of routine seasonal respiratory infectious diseases. The company's fully automated biochemical analyzer and supporting series of freeze-dried biochemical reagents have obtained certification in Peru, broadening the range of saleable product categories in the South American market. These products are used for auxiliary detection of hepato-pancreatic system, urinary system, cardiovascular diseases, as well as glucose metabolism disorders, lipid metabolism disorders, and water-salt metabolism disorders, which is beneficial for overall market expansion in South America.

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