Group 1 - The company has received notification from the EU regulatory body regarding the addition of multiple products to its Medical Device Regulation (MDR) certification [1] - The MDR certification indicates that the products comply with the latest EU medical device regulations, allowing for legal sales in relevant overseas markets [1] - The certification is expected to enhance the promotion and sales of the company's products in the corresponding markets [1] Group 2 - The actual sales performance of the newly certified products in overseas markets will depend on future marketing efforts, and the specific impact on the company's future operating performance remains unpredictable [1]

Core Viewpoint - The company, Weili Medical (603309.SH), has received notification from the EU announcement agency regarding the addition of multiple products to its EU Medical Device Regulation (MDR) certification [1] Group 1 - The newly certified products comply with the latest EU medical device regulations, indicating they meet the current market access requirements in the EU [1] - The EU MDR certification allows the company to legally sell its products in relevant overseas markets, enhancing the promotion and sales of its products in those markets [1]

Product Information - The continuous glucose monitoring system (CGM) developed by Jiangsu Yuyue Kailite Biotechnology Co., Ltd., a subsidiary of the company, has obtained EU MDR certification [1] - The certified products include the Anytime 4 and Anytime 5 series CGM devices [2] - The certification is valid from January 27, 2026, to January 26, 2031, and allows for real-time monitoring of interstitial glucose levels [2] Impact Analysis - The certification meets the latest EU market access requirements, enabling sales in countries that recognize EU MDR qualifications [2] - It enriches the company's international product portfolio, enhancing its competitiveness in the diabetes care sector [2] - The certification is expected to facilitate business development in the EU and other countries that recognize MDR certification [2]

Core Viewpoint - Sanxin Medical has received EU MDR certification for several medical products, indicating compliance with EU regulations and enhancing market access in EU countries and other regions recognizing this certification [1] Group 1: Certification Details - The products certified include single-use blood dialysis tubing, single-use blood collection devices, single-use sterile injection needles, single-use retractable self-destructing sterile syringes with needles, single-use precision filter infusion sets, single-use infusion sets, and single-use sterile dialysis care packages [1] - The certification type is EU Certificate, issued by TÜV Rheinland LGA Products GmbH, a German certification body [1] - The approval date for the certification is January 20, 2026, covering Class Ib, Class IIa, and Class Is products [1] Group 2: Market Implications - The certification signifies that the company has established a quality management system that meets EU MDR regulatory requirements [1] - This approval is expected to positively impact the promotion and sales of the company's products in EU countries and other nations that recognize EU MDR certification [1]