鱼跃医疗高品质产品海外获证提速 国产医械顺势出海

Core Viewpoint - Yuyue Medical has signed a strategic cooperation agreement with Inogen, a leading portable oxygen machine manufacturer in the U.S., marking a new phase in its North American market expansion and supporting its global strategy [1] Group 1: Company Overview - Founded in 1998, Yuyue Medical has become a leader in the domestic medical device industry, breaking the foreign brand monopoly through over 20 years of technological advancements [2] - The company offers a wide range of products across various fields, including respiratory oxygen, diabetes care, home testing, emergency care, traditional Chinese medicine, rehabilitation, disinfection, and ophthalmology, with over 600 product types and nearly 10,000 specifications [2] - Yuyue Medical serves 300,000 medical institutions globally, covering over 90% of top-tier hospitals in China and operating in 131 countries and regions [2] Group 2: Global Strategy and Market Expansion - In the first half of 2024, Yuyue Medical's overseas revenue reached 479 million yuan, a year-on-year increase of 30.19% [3] - The company has established over 50 channel agents in regions such as Southeast Asia, the Middle East, North Africa, and Europe and North America, creating a comprehensive R&D, production, marketing, and service network covering over 130 countries and regions [3] - Yuyue Medical has become a significant exhibitor at major international medical device exhibitions, enhancing the global perception of Chinese medical device brands [3] Group 3: Product Quality and Certifications - Yuyue Medical has accelerated the acquisition of overseas market access qualifications, obtaining 64 overseas registrations in 2023 and 52 in the first half of 2024 [4] - Key products have received certifications from the U.S. FDA, EU MDR, and Korea KGMP, establishing a solid foundation for market expansion [4] - The company's automated external defibrillator (AED) recently passed the EU's Class III medical device CE certification, facilitating rapid growth in its emergency business in the EU and other countries recognizing EU MDR certification [4] Group 4: Innovation and Future Outlook - Yuyue Medical emphasizes strict quality control and continuous innovation as the foundation of its successful global strategy [4] - The company is advancing digital transformation by introducing leading smart production lines and establishing national-level smart manufacturing factories to ensure product quality through comprehensive data management [4] - Yuyue Medical plans to continue focusing on user needs, increasing R&D investment, and enhancing product quality and service capabilities to achieve greater breakthroughs in the global market [5]