上述产品获得欧盟 MDR 认证，表明其符合欧盟最新医疗器械法规要求，具备欧盟市场的最新准入条 件，可以在相关海外市场合法销售，对公司产品在相应市场的推广和销售起到推动作用。 智通财经APP讯，维力医疗(603309.SH)发布公告，公司近日收到欧盟公告机构通知，公司欧盟医疗器 械法规(Medical Device REGULATION (EU) 2017/745，简称"MDR")认证证书中新增了多个产品的欧盟 MDR 认证。 ...

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]

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]