证券代码：688575 证券简称：亚辉龙 公告编号：2025-049 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"或"亚辉龙"）于近日收到了由BSI Group The Netherlands B.V.签发的IVDR CE最高风险等级Class D认证证书，具体信息如下： 董事会 2025年9月6日 ■ 新的欧盟体外诊断医疗器械法规（IVDR, EU 2017/746）已替代原欧盟体外诊断医疗器械指令（IVDD, 98/79/EC）对欧盟市场的体外诊断医疗器械进行管理。 截至目前，公司累计已有226个产品获得IVDR CE认证。根据欧盟体外诊断医疗器械法规的规定，本次 获得认证的产品已经具备进入欧盟市场的必要条件，对公司在欧盟地区及认可CE认证地区的业务推广 将产生积极影响，但产品具体销售情况受到市场等因素影响，公司尚无法预测上述产品对公司未来业绩 的影响，敬请广大投资者理性投资，注意投资风险。 ...

Core Points - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its products under the IVDR CE marking [1] - A total of 226 products have now obtained IVDR CE certification, allowing them to enter the EU market [1] - The certification will positively impact the company's business promotion in the EU and CE-recognized regions, although the specific sales performance remains uncertain due to market factors [1]

| 序号 | 产品名称 | 证书编号 | 有效期 | 临床用途 | | --- | --- | --- | --- | --- | | | iFlash-HBsAg 乙型肝炎柄毒衣 | IVDR 781230 | 全 2030/09/01 | 用于定量检测人血清或血浆中 的乙型肝炎表面抗原,辅助诊断 | | | 面抗原测定试剂 盒(化学发光法) | IVDR 742445 | 4 | 乙型肝炎病毒感染和用于献血 筛查。 | | | | | 2026/10/18 | | | 2 | iFlash-Anti-HBs 乙型肝炎病毒衣 | IVDR 781231 | 至 | 用于定量检测人血清或血浆中 的乙型肝炎表面抗体,辅助监测 | | | | | 2030/09/01 | | | | 面抗体测定试剂 | | | 乙肝疫苗接种效果或感染者康复进程 | | | 盒(化学发光法) | IVDR 742445 | 中 | | | | | | 2026/10/18 | | | | | | | 51 6 5 | 格隆汇9月5日丨亚辉龙(688575.SH)公布，近日收到了由BSIGroupTheNetherlandsB.V. ...

Group 1 - Shenzhen Pumen Technology Co., Ltd. has recently obtained IVDR CE certification for seven electrochemiluminescence reagent products from T?V S?D Group, which is a significant achievement for the company [1] - The certified products include various prostate-specific antigen kits and other diagnostic assays, which are intended for cancer screening, diagnosis, and monitoring [1] - With the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), the company has now a total of 27 electrochemiluminescence reagent products certified, enhancing its competitiveness in the EU market [1] Group 2 - The IVDR CE certification allows the company’s products to enter the EU market, which is expected to positively impact the company's future operations [1]