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We are thrilled to announce that our MeCross CTO PTCA Balloon Dilatation Catheter has received the prestigious CE MDR certification! This milestone signifies that Medoo products meet the highest international standards in terms of safety, efficacy, and clinical performance, providing a strong guarantee for continuing to maintain and increase its market share in Europe.
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. Technological Breakthroughs, Precise Treatment
The MeCross CTO PTCA balloon catheter is specifically designed for chronic total occlusion lesions and offers the following core advantages:
High Efficiency: The optimized catheter design enhances the ability to navigate complex lesions, improving surgical success rates.
Precise Control: The unique delivery system enhances maneuverability, helping doctors perform interventional treatments more accurately.
Rich size matrix: 48 specifications, minimum diameter 1.0mm, suitable for a variety of clinical scenarios.
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. Advancing Global Strategy
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.
Brochure：http://hk135892.hkpic1.websiteonline.cn/upload/CTO-618eng.pdf