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一次性使用机用采血器等
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三鑫医疗:公司产品通过欧盟MDR认证
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]