亚辉龙(688575.SH)：取得IVDR CE认证

Core Points - Aihua Long (688575.SH) has received the highest risk level Class D certification from BSI Group The Netherlands B.V. under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), which replaces the previous directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] Product Certification Details - Product Name: iFlash-HBsAg Hepatitis B Surface Antigen - Certificate Number: IVDR 781230 - Valid Until: September 1, 2030 - Clinical Use: Quantitative detection of Hepatitis B surface antigen in human serum or plasma, assisting in diagnosis [2] - Product Name: iFlash-Anti-HBs Hepatitis B Surface Antibody - Certificate Number: IVDR 781231 - Valid Until: September 1, 2030 - Clinical Use: Quantitative detection of Hepatitis B surface antibody in human serum or plasma, assisting in monitoring vaccination effects or recovery progress of infected individuals [2]