Orient Biotech's subsidiary obtains medical device registration certificate

Zhitong
2025.09.09 09:17
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Orient Biotech's wholly-owned subsidiary Healgen Scientific LLC and its holding subsidiary Hangzhou Laihe Biotechnology Co., Ltd. recently obtained multiple medical device registration certificates. These products include respiratory combined detection reagents and fully automated biochemical analyzers, which have been certified in China, the European Union, Israel, and Peru, expanding the company's product range in related markets and helping to address the testing of seasonal respiratory infections and other diseases

According to the Zhitong Finance APP, Orient Biotech (688298.SH) announced that its wholly-owned subsidiary Healgen Scientific LLC (referred to as "Healgen USA") and its holding subsidiary Hangzhou Laihe Biotechnology Co., Ltd. (referred to as "Laihe Biotechnology") have recently obtained registration certificates for multiple medical device products.

The company's aforementioned respiratory combined detection reagents have been certified in China, the European Union, and Israel, further enriching and improving the company's product layout for respiratory combined detection in these countries and regions, expanding the variety of products available for sale, and facilitating the detection of routine seasonal respiratory infection diseases. The company's fully automatic biochemical analyzer and a series of supporting lyophilized biochemical reagents have been certified in Peru, broadening the range of products available for sale in the South American market, used for auxiliary detection of liver and pancreatic systems, urinary systems, cardiovascular and cerebrovascular diseases, as well as disorders of glucose metabolism, lipid metabolism, and water-salt metabolism, which is beneficial for the overall expansion of the South American market