New Industries Biomedical gains key medical device registration for hypertension detection

Shenzhen New Industries Biomedical Engineering Co., Ltd. recently obtained a new medical device registration certificate from the Guangdong Provincial Medical Products Administration. The certificate is for its "Angiotensin I Assay Kit (Magnetic Chemiluminescence Immunoassay)," classified as a Class II medical device, valid from December 5, 2025, to December 4, 2030. This kit is designed for the in vitro quantitative determination of human plasma angiotensin I, aiding in the auxiliary evaluation of cardiovascular function.

This innovative third-generation product uses a small molecule sandwich method and novel antibodies that recognize antigen-antibody complexes, enhancing sensitivity, precision, and specificity. This advancement is expected to boost the company's competitiveness in the hypertension detection market, a critical area given the rising prevalence of hypertension and its associated health risks.

The company now holds 197 chemiluminescence reagent medical device registration certificates, totaling 283 registrations. This latest addition expands its "hypertension" project category within its chemiluminescence detection product portfolio, which is anticipated to have a positive impact on the company's development. However, the company notes that this will not significantly affect its short-term production, operations, or financial performance.