Snibe obtains registration certificates for medical devices

Shenzhen New Industries Biomedical Engineering Co., Ltd. (SZSE:300832) announced it has received medical device registration certificates for four new products. The National Medical Products Administration granted registration for an IgM and an IgG antibody detection kit for Hepatitis E virus (HEV), utilizing chemiluminescence immunoassay with magnetic microparticles. Additionally, the Guangdong Provincial Drug Administration issued registration certificates for a zinc assay reagent kit (PAPS chromogenic method) and a direct bilirubin assay reagent kit (diazo salt method). These new approvals broaden SNIBE’s range of diagnostic solutions within infectious diseases and biochemical assays, particularly in assessing liver function and inorganic ions. The company holds 195 chemiluminescence reagent "Medical Device Registration Certificates" (totaling 279 registrations) and 69 biochemical reagent "Medical Device Registration Certificates" (totaling 102 registrations). While SNIBE anticipates a positive impact from these additions, it cautions that the immediate effect on production and operations may not be significant, advising investors to exercise caution.