亚辉龙:HIV检测试剂盒获IVDR CE最高风险等级Class D认证
Core Viewpoint - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its iFlash - HIV Combo test kit, marking a significant achievement in its product certification journey [1] Group 1 - The HIV test kit has successfully passed the IVDR CE certification, which is crucial for market entry in the European Union [1] - This certification covers the full range of eight preoperative chemiluminescent test reagents, bringing the total number of certified products to 229 [1] - The certification is expected to positively impact business promotion, although the exact effect on performance remains unpredictable [1]