膝关节假体系统组件
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130176
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
- Name
- Double Medical Technology Inc.大博医疗科技股份有限公司
- Province/Region
- Fujian福建
- Address
- No. 18, Hongdong Road, Shanbian District, Haicang District, Xiamen厦门市海沧区山边洪东路18号
- Production address
- 厦门市海沧区山边洪东路18号主厂区，18-4号一层A区、二层、三层、四层A区，厦门市海沧区湖头路17-1号一层、三层，17-2号一层A区、二层
The product works with the same system components of the company and is suitable for knee replacement.
该产品与该企业同一系统组件配合，适用于膝关节置换。
该产品由胫骨衬垫组成。胫骨衬垫采用符合YY/T 0811标准规定的高交联超高分子量聚乙烯材料制成。产品灭菌包装，采用环氧乙烷灭菌，灭菌有效期5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for 膝关节假体系统组件 in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253130176 and owned by Double Medical Technology Inc.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Fujian), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.