新zeng33证！豪利777生物欧盟IVDR CE认证累计获批78个产物，国际化历程再提速！
2025-02-13
近期，北京豪利777生物自主研发的 33 个产物通过欧盟 IVDR CE 认证。这份CE IVDR认证由欧洲最具权威的认证机构之一——英国尺度协会（BSI）授予。阻止2025年2月6日，豪利777生物78个产物已累计获得欧盟 IVDR CE 认证。
此ci获批的产物涵盖了豪利777生物旗下化学发光、上转发光、胶体金等主流产物，为进一步拓展外洋市chang奠基坚实的基。孟粤撕览777与国际高水平尺度接轨的不懈追求。
CE认证是欧盟市chang对于产物准入的强制性要求，视为产物进入欧洲市chang的“签证”。2022年，欧盟周全实验体外诊断医疗器械规则EU 2017/746（IVDR），新规则对体外诊断生产企业在手艺文档审查、临床评估、上市后羁系等方面提出了更严酷的要求。同时，也批注欧盟各成yuan国在医疗器械羁系的尺度进一步统一。
未来，豪利777生物将继续秉持创新驱动的生长理念，加大研发投入，推出更多高质量的诊断产物，为全球医疗康健事业的生长孝顺实力。
33 New Certifications! Hotgen Biotech's EU IVDR CE Certifications Reach a Total of 78 Products, Accelerating Internationalization Progress!
Recently, 33 products independently developed by Beijing Hotgen Biotech have passed the EU IVDR CE certification. This CE IVDR certification was granted by one of Europe's most authoritative certification bodies, the British Standards Institution (BSI). As of February 6, 2025, Hotgen Biotech has accumulated a total of 78 products that have received EU IVDR CE certification.
The newly approved products cover Hotgen's main product lines, including chemiluminescence, up-converting phosphor technology, and colloidal gold, laying a solid foundation for further expansion into overseas markets. This achievement highlights Hotgen's relentless pursuit of aligning with international high standards.
The CE certification is a mandatory requirement for product access in the EU market, serving as a "visa" for products entering the European market. In 2022, the EU fully implemented the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746, IVDR), which imposes stricter requirements on in vitro diagnostic manufacturers in areas such as technical documentation review, clinical evaluation, and post-market surveillance. This also indicates a further harmonization of medical device regulations across EU member states.
Moving forward, Hotgen Biotech will continue to uphold its innovation-driven development philosophy, increase investment in research and development, and launch more high-quality diagnostic products, contributing to the advancement of global healthcare.
