HANGZHOU, China – Singclean today announced that its Medical Sodium Hyaluronate Gel for Bone Joint product has officially obtained the CE certification under the European Union Medical Device Regulation (MDR) 2017/745!

就在今天，协合医疗旗下骨科医用透明质酸钠凝胶正式取得欧盟MDR CE认证！

Left: Mr. Sun Weiqing, General Manager of Singclean Medical

Right: Ms. Eftang, Cathrine Norstad, Head of Clinical Review at DNV Headquarters

左：孙伟庆先生 右：Eftang, Cathrine Norstad女士

The certificate was personally presented by Ms. Eftang, Cathrine Norstad, Head of Clinical Review at DNV Headquarters, to Mr. Sun Weiqing, General Manager of Singclean Medical, who accepted this prestigious recognition on behalf of the company.

证书由DNV总部临床评审负责人Eftang, Cathrine Norstad女士亲自颁发，协合医疗总经理孙伟庆先生代表公司接受这一权威荣誉。

This achievement sets multiple industry records: it is the first MDR CE certificate for hyaluronic acid-based orthopedic products ever issued by DNV worldwide. Singclean Medical has become the first Chinese company to obtain such certification in this category and has successfully ranked among the first 3 companies globally to secure a viscosupplementation MDR CE certificate. This accomplishment underscores Singclean Medical's technological expertise and international competitiveness in the field of orthopedic biomaterials and hyaluronic acid applications.

此次认证创造了多项行业纪录：这是DNV在全球范围内签发的首张透明质酸骨科类MDR CE证书；协合医疗为中国首家获此证书的企业，更成功跻身全球前三。这一成绩，充分彰显了协合医疗在骨科生物医用材料及透明质酸领域的技术积累与国际竞争力。

The EU MDR represents one of the most stringent regulatory frameworks in the global medical device industry, imposing rigorous requirements across technical documentation, clinical evaluation, risk management, post-market surveillance, and quality management systems. Singclean Medical's successful navigation of the comprehensive review process not only demonstrates the company's robust capabilities in product R&D, international regulatory compliance, and end-to-end quality control, but also reflects the rigorous and professional auditing standards of DNV—one of the few international notified bodies authorized for both MDR and IVDR certification.

欧盟MDR作为当前全球医疗器械法规体系中标准最严、要求最高的体系之一，对产品技术文档、临床评价、风险管理、上市后监管及质量体系均设有极其严格的准入门槛。协合医疗能够顺利通过全流程评审，不仅体现了公司在产品研发、国际注册合规和质量管控方面的综合实力，也印证了DNV作为少数同时获得MDR和IVDR授权的国际公告机构的专业审核能力。

This certification serves as compelling evidence of Singclean Medical's technological strength and clinical value for its orthopedic products in the EU market.It will further ensure that European patients suffering from osteoarthritis have access to high-quality treatment options, effectively alleviating pain and improving joint function. At the same time, this landmark achievement injects strong momentum into Singclean Medical's global strategic layout and establishes a new benchmark for Chinese-made biomedical materials entering the world stage.

此次认证的取得，既是协合医疗骨科产品在欧盟市场技术实力与临床价值的有力证明，也将进一步保障欧洲骨关节炎患者获得优质治疗选择，切实缓解疼痛、改善关节功能。同时，这一里程碑事件为协合医疗的全球化战略布局注入了强劲动力，也为中国生物医用材料走向世界树立了新的标杆。

Looking ahead, Singclean Medical will continue to deepen its strategic collaboration with DNV and other internationally recognized certification bodies, jointly driving the high-quality development of premium Chinese medical devices across European and global markets, and contributing China's strength to the advancement of global healthcare.

未来，协合医疗将持续深化与DNV等国际权威认证机构的战略合作，携手推动国产高端医疗器械在欧洲及全球市场的高质量发展，为世界医疗健康事业贡献中国力量。