Hip prosthesis Double-action acetabular lining
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130152
- 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
Works with the same system components as the enterprise for hip replacement.
与该企业同一系统组件配合，适用于髋关节置换。
该产品由双动内衬组成，双动内衬采用符合ASTM F2695标准的含维生素E的高交联超高分子量聚乙烯材料制成；产品采用环氧乙烷灭菌包装，灭菌有效期5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Hip prosthesis Double-action acetabular lining 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20253130152 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.