1.MDR认证：高标准，严要求

CE认证是医疗器械进入欧洲市场的强制性准入要求。2017年5月，欧盟颁布了更严格的医疗器械新法规MDR（EU 2017/745），取代原有的MDD指令。新规大幅提升了对医疗器械临床数据、风险管理和可追溯性的要求，对企业的技术实力和质量管理体系提出了更高挑战。此次脉动医学半顺应性PTCA球囊扩张导管(MeCross CTO)成功获证，不仅体现了其产品的卓越性能，也展现了公司在国际合规化进程中的领先地位。

CE certification is a mandatory entry requirement for medical devices entering the European market. In May 2017, the EU enacted stricter regulations under the MDR (EU 2017/745), replacing the previous MDD directive. The new regulations significantly enhance the requirements for clinical data, risk management, and traceability of medical devices, posing higher challenges to companies' technical capabilities and quality management systems. The successful MDR Certification of MeCross CTO PTCA Balloon Dilatation Catheter not only reflects the product's outstanding performance but also showcases Medoo's leading position in the international compliance process.

2.技术突破，精准治疗

Technological Breakthroughs, Precise Treatment

脉动医学半顺应性PTCA球囊扩张导管（MeCross CTO） 具备以下核心优势：

The MeCross CTO PTCA balloon catheter is specifically designed for chronic total occlusion lesions and offers the following core advantages:

高效通过性：优化的导管设计，提升复杂病变的通过能力，提高手术成功率。

High Efficiency: The optimized catheter design enhances the ability to navigate complex lesions, improving surgical success rates.

精准操控：独特的推送系统增强操控性，帮助医生更精准地完成介入治疗。

Precise Control: The unique delivery system enhances maneuverability, helping doctors perform interventional treatments more accurately.

型号覆盖广：48 种规格，最小直径1.0mm，适配多种临床场景。

Rich size matrix: 48 specifications, minimum diameter 1.0mm, suitable for a variety of clinical scenarios.

该产品此前已获得中国国家药品监督管理局（NMPA）三类医疗器械注册证，此次MDR认证的通过，标志着脉动医学进一步巩固了其在全球主流核心医疗市场的血管介入领域的领先地位。

The product has previously obtained a Class III medical device registration certificate from the National Medical Products Administration (NMPA) in China. The successful MDR certification further consolidates Medoo Medical's leading position in the global core medical market for vascular intervention.

3.全球化战略再进一步

Advancing Global Strategy

欧洲是全球重要的医疗器械市场，MDR认证的获得为脉动医学持续深入欧洲及其关联市场提供了强有力的支持。公司将继续推进国际化战略，加强与全球医疗机构和专家的合作，让更多患者受益于创新的血管介入治疗方案。

Europe is a significant market for medical devices globally, and the acquisition of MDR certification provides robust support for Medoo Medical to deepen its presence in Europe and related markets. The company will continue to promote its international strategy, strengthening collaborations with global medical institutions and experts, allowing more patients to benefit from innovative vascular interventional treatment solutions.

中文彩页：http://hk135892.hkpic1.websiteonline.cn/upload/CTO-618.pdf

Brochure：http://hk135892.hkpic1.websiteonline.cn/upload/CTO-618eng.pdf