捷报频传！海内首张小型化学发光平台适配试剂CE IVDR证书花落q千亿球友会
2024-06-17
近日，q千亿球友会乐成获得了欧盟体外诊断医疗器械规则（IVDR）下的CE认证，跻身海内少数率先获得该尺度认证的IVD厂商之列。这也是海内单人份化学发光类产物获得的首张CE IVDR证书,由欧洲最有声望的认证机构之一英国尺度协会（BSI）发表。这一里程碑式成就，不仅标志着q千亿球友会的产物切合欧盟新规则的要求，获得了国际高规则要求市场的准入许可，更彰显了我国诊断试剂行业不停提升的国际竞争力。
q千亿球友会首批获得CE IVDR认证的产物涵盖了心肌、炎症、激素、肿瘤等多个重要临床检测领域中的14个要害诊断指标。这些产物的乐成认证得益于q千亿球友会在研发、生产、质量控制等方面，与国际高水平尺度接轨的不懈追求，也印证了q千亿球友会创新诊断产物在全球市场领先的品牌认可度。
创新诊断，价值检验。展望未来，q千亿球友会将继续承袭“生长生物科技，造福人类康健”的使命，坚持守正创新，连续提升产物竞争力，为宽大患者和医疗机构提供更多优质诊断试剂息争决方案，推动我国诊断试剂行业迈向更岑岭，为全球医疗事业孝敬中国力量。让球友会官网配合期待，我国诊断试剂行业在国际舞台上绽放越发耀眼的光线，为全球公共康健福祉带来更大孝敬！
Recently, Hotgen receives its first CE IVDR Certificate for chemiluminescent immunoassays (CLIA) from BSI, one of the most reputable notified bodies for CE certifications of medical devices. This is also the first CE IVDR certificate granted to Chinese mono-test CLIA products. This certificate covers 14 Hotgen mono-test CLIA reagents concerning cardiac, hormones, inflammation, cancer and other important physiological markers, involving both class B and C reagents.
The Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices is the new EU legislation for in-vitro diagnostic (IVD) medical devices. On May 26th, 2022, the Regulation (EU) 2017/746 (IVDR) fully applies across the European Union region. The 14 newly certified products are evidences of Hotgen’s unwavering commitment to safety, quality, and effectiveness of diagnostic products, as well as loyalty to the demand of healthcare professionals and patients.
As the first CE IVDR certificate granted to a Chinese mono-test CLIA manufacturer, this certificate marks a new step in Hotgen’s endeavor to the international market. Hotgen’s mono-test CLIA solution involves innovative designs such as mono-test cartridges and durable device platforms. It has been widely recognized and accepted by over 10,000 medical institutions worldwide, as a choice of diagnostic products with precision, economy, and flexibility.
Holding the mission of “Developing biotechnology, Benefiting human health”, Hotgen will continue researching, registering, and supplying high-quality precision diagnostic products worldwide. We are fully confident in having more Hotgen products registered and recognized in the EU and around the world in near future.
