Workflow
医疗器械法规认证
icon
Search documents
天益医疗相关产品获得欧盟MDR认证
Zhi Tong Cai Jing· 2025-11-05 04:15
Core Viewpoint - Tianyi Medical (301097.SZ) has received the EU Medical Device Regulation (MDR) certification for several of its products, indicating compliance with the latest EU medical device regulations and enabling continued legal sales in relevant overseas markets [1] Product Certification - The certified products include: - Extracorporeal Blood Tubing Set - Oral/Enteral Syringe - Oral/Enteral Syringe with ENFit connector - Arterial-Venous Fistula Needle Set [1] Market Implications - The acquisition of MDR certification allows the company to meet the latest market entry conditions in the EU, which is expected to enhance the promotion and sales of its products in corresponding markets [1]
维力医疗:控股子公司产品获欧盟MDR认证
news flash· 2025-05-06 08:20
Core Viewpoint - Vigor Medical (603309) announced that its subsidiary, Suzhou Medtronic, has recently obtained the EU Medical Device Regulation (MDR) certification for its products, which include portable infusion pumps and single-use liquid storage boxes [1] Group 1 - The certification was issued by TüV SüD Product Service GmbH, with a signing date of April 29, 2025, and is valid until April 28, 2030 [1] - This certification indicates that the products meet the latest EU medical device regulatory requirements, allowing for compliance with the latest market access conditions in the EU [1] - The certification is expected to facilitate the promotion and sales of the company's products in relevant overseas markets [1]