Shenzhen New Industries Biomedical Engineering (300832.SZ) products have obtained IVDR CE certification.

Shenzhen New Industries Biomedical Engineering (300832.SZ) announced that their human immunodeficiency virus antigen and antibody test kit (chemiluminescent immunoassay) has obtained the IVDRCE highest risk level Class D certification issued by the EU notified body - TV Sd Deutschland Group. The new EU regulation on in vitro diagnostic medical devices (IVDR, EU2017/746) replaces the original EU directive on in vitro diagnostic medical devices (IVDD, 98/79/EC) for the management of in vitro diagnostic medical devices in the EU market. As of now, the company has obtained IVDR CE certification for a total of 169 chemiluminescent reagents and 58 biochemical reagents. According to the provisions of the EU regulation on in vitro diagnostic medical devices, the products that have obtained IVDR CE certification this time already have the necessary conditions to enter the EU market, and will further enhance the comprehensive competitiveness of the company's products, which will have a positive impact on the company's future operations.