普门科技获多项产品获IVDR CE认证

Core Viewpoint - The company, Pumen Technology (688389.SH), has received IVDR CE certification for 26 electrochemical luminescent reagent products and hemoglobin chromatography columns, indicating compliance with the new EU regulations for in vitro diagnostic medical devices [1] Group 1 - The new EU In Vitro Diagnostic Medical Device Regulation (IVDR, EU2017/746) replaces the previous In Vitro Diagnostic Medical Device Directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] - The company has achieved a total of 53 electrochemical luminescent reagent products certified under IVDR CE [1]