Core Viewpoint - Shenzhen Aihuilong Biotechnology Co., Ltd. has received the IVDR CE certification for its products, which allows them to enter the EU market, positively impacting business promotion in the region [1]. Group 1: Certification Details - The company has obtained the highest risk level Class D certification under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), replacing the previous directive (IVDD, 98/79/EC) [1]. - A total of 226 products have received IVDR CE certification to date, indicating the company's compliance with the new regulatory requirements [1]. Group 2: Market Impact - The certification provides necessary conditions for the company's products to enter the EU market and regions that recognize CE certification, which is expected to have a positive impact on business promotion [1]. - However, the company cannot predict the specific sales performance of these products due to market factors, emphasizing the need for rational investment by stakeholders [1].
深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得IVDR CE认证的公告