Kehua Bio-Engineering subsidiary secures medical device registration for immunoassay analyzer

Shanghai Kehua Bio-Engineering Co., Ltd. announced that its wholly-owned subsidiary, Kehua (Xi'an) Bio-Engineering Co., Ltd., has obtained a medical device registration certificate from the Shaanxi Provincial Medical Products Administration. The certificate is for an "Automatic Chemiluminescence Immunoassay Analyzer."

The registration certificate is valid from December 3, 2025, to December 2, 2030. This new device is intended for use in conjunction with corresponding detection reagents for qualitative or quantitative analysis of analytes in human serum, plasma, and other bodily fluid samples in clinical settings.

Kehua Bio-Engineering stated that this new medical device registration certificate enriches the company's product line and is expected to have a positive impact on its business development. However, the company is currently unable to predict the impact of this product on its future operating revenue and advises investors to pay attention to investment risks.