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]

普门科技公告，近日公司7项电化学发光试剂产品获得欧盟公告机构T V南德意志集团签发的IVDR CE 认证。 ...

普门科技公告，公司近日获得欧盟公告机构T V南德意志集团签发的IVDR CE认证，涉及13项电化学发 光试剂产品。产品包括抗甲状腺球蛋白抗体、C肽、总三碘甲状腺原氨酸、总甲状腺素、甲状腺结合球 蛋白、游离三碘甲状腺原氨酸、游离甲状腺素、雌二醇、促卵泡生成素、促黄体生成素和泌乳素、睾酮 等测定试剂盒。这些产品均属于ClassB分类，有效期至2029年6月23日。新的欧盟体外诊断医疗器械法 规(IVDR)替代原指令(IVDD)对欧盟市场的体外诊断医疗器械进行管理。截至目前，公司已有累计20项 电化学发光试剂产品获得IVDR CE认证。本次获得认证的产品已具备进入欧盟市场的必要条件，有利于 提升公司在欧盟市场的竞争力，对公司未来的经营将产生积极影响。 ...