东方生物(688298.SH)：公司及控股子公司杭州莱和获得医疗器械注册证

Core Viewpoint - Dongfang Biological (688298.SH) has recently obtained registration certificates for several medical device products, enhancing its product portfolio in respiratory testing and expanding its market reach domestically and internationally [1] Domestic Medical Device Registration - The company has received a registration certificate for the Mycoplasma pneumoniae antigen detection kit (latex method), with certificate number: National Medical Device Approval 20253402221 [1] International Medical Device Registration - The company has secured registration for multiple antigen detection kits, including: - Influenza A and B antigen detection kit (colloidal gold) - Helicobacter pylori antigen detection kit (feces) - Helicobacter pylori antibody detection kit (whole blood/serum/plasma) - Influenza A antigen detection kit (colloidal gold) - Respiratory syncytial virus antigen detection kit - COVID-19/Influenza antigen detection kit (colloidal gold) - A seven-in-one respiratory test kit for COVID-19/Influenza A and B/RSV/adenovirus/Mycoplasma pneumoniae/human metapneumovirus - A six-in-one respiratory test kit for COVID-19/Influenza A and B/RSV/adenovirus/Mycoplasma pneumoniae - A five-in-one respiratory test kit for COVID-19/Influenza A and B/RSV/adenovirus - A four-in-one respiratory test kit for COVID-19/Influenza A and B/RSV - A two-in-one respiratory test kit for RSV/adenovirus - Certificate number: IVDR792590 [1] Market Expansion - The acquisition of these respiratory joint detection test kits in both domestic and EU markets enriches and enhances the company's product offerings in respiratory testing, facilitating the detection of seasonal respiratory infections and overall market expansion for related products [1]