欧盟“设限”中企医疗器械 蓝帆医疗“三角支撑”体系筑牢抗风险壁垒

Core Viewpoint - The European Union has voted to restrict Chinese medical device manufacturers from entering its procurement market, which could significantly impact companies like Bluestar Medical, although the company has developed strategies to mitigate risks associated with international trade policies [1][2]. Group 1: Impact of EU Decision - The EU's decision could ban Chinese companies from participating in tenders exceeding €5 million for five years, which may limit their access to a large market [1]. - Bluestar Medical's low-value consumables segment is expected to be minimally affected, as individual glove tender sizes are unlikely to reach the €5 million threshold [1]. - The company anticipates maintaining stable operational rhythms in its glove business despite the EU ban [1]. Group 2: Strategic Positioning - Bluestar Medical's cardiovascular business has effectively avoided the EU ban's impact through its overseas production bases in Singapore and Germany, ensuring that its international products are manufactured abroad [2]. - The company has established a "China innovation + global delivery" model, with localized R&D, production, and sales teams across China, Singapore, and Germany, creating a robust support system covering Asia-Pacific and Europe [2]. - This globalized production layout allows the company to respond effectively to potential future trade barriers [2]. Group 3: Product Development and Innovation - The cardiovascular division is experiencing a product harvest period in 2024, with several key products being launched, including the coronary artery balloon dilation catheter [3]. - The company has developed a comprehensive clinical solution with its products, marking a transition from simple to complex PCI lesion solutions [3]. - Bluestar Medical has built a full-chain international operation system and a marketing network that spans over 130 countries, positioning itself to withstand unpredictable global trade conditions [3].