Shenzhen new industries obtains medical device registration

Shenzhen New Industries Biomedical Engineering (SZSE:300832) announced that it has received a medical device registration certificate from the Guangdong Provincial Drug Administration for its C-Reactive Protein (CRP) assay kit (Latex Immunoturbidimetry). The registration, under certificate number 粵械注准20252400665, is valid from May 6, 2025, to May 5, 2030. The kit is designed for the in vitro quantitative determination of CRP in human serum or plasma and is intended for the adjunctive diagnosis of non-specific inflammation. The company notes that this approval expands its "Inflammation Monitoring" product category and is a re-registration of its second-generation product. While the company expects a positive impact on its development, it anticipates no significant short-term impact on its production operations or financial performance. Shenzhen New Industries has now secured 67 biochemical reagent medical device registration certificates, encompassing a total of 99 registration certificates.