Kehua Bio-Engineering secures new medical device registration for ferritin assay kit

Shanghai Kehua Bio-Engineering Co., Ltd. announced today that it has received a medical device registration certificate from the Shanghai Municipal Drug Administration for an in-vitro diagnostic reagent. The newly approved product, a Ferritin Assay Kit (latex enhanced immunoturbidimetry), bears the registration number 20252400408.

The registration certificate is valid from September 17, 2025, to September 16, 2030. This kit is intended for medical institutions to quantitatively measure ferritin in human serum and plasma samples. Clinically, it will primarily assist in the diagnosis of iron metabolism-related diseases, including hemochromatosis and iron-deficiency anemia.

The company stated that the acquisition of this new medical device registration certificate enriches its product line and is expected to have a positive impact on its business development. However, the company currently cannot predict the influence of this product on its future operating revenue, and investors are advised to pay attention to and be aware of investment risks.