Kehua bio-engineering unit secures new medical device registration

Shanghai Kehua Bio-Engineering Co., Ltd. announced today that its controlled subsidiary, Xi'an Tianlong Technology Co., Ltd., has obtained a medical device registration certificate from the National Medical Products Administration. The certificate is for an in-vitro diagnostic reagent, specifically the "Human ALDH2 Gene Polymorphism Detection Kit (Fluorescent PCR Method)." The registration certificate number is 20253402670.

The registration is valid from December 23, 2025, to December 22, 2030. This kit is designed for the in-vitro qualitative detection of ALDH2 gene c.1510G>A locus polymorphisms in human whole blood samples.

The company stated that this new medical device registration certificate enriches its product line and is expected to positively impact its business development. However, Shanghai Kehua Bio-Engineering noted it is currently unable to predict the product's impact on future operating revenue and advises investors to be aware of investment risks.