复合聚醚醚酮界面螺钉
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130133
- 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
It is used to fix soft tissues with knee ligaments, including bones connected to ligaments or tendons.
用于膝关节韧带固定软组织，包括骨骼与韧带或肌腱连接。
本产品由界面螺钉和外鞘组成，采用双相磷酸钙（BCP）（羟基磷灰石、磷酸钙）共混聚醚醚酮树脂制成，其中界面螺钉牌号为VESTAKEEP iC4800G，外鞘牌号为VESTAKEEP iC4800R。产品灭菌包装，采用环氧乙烷灭菌，灭菌有效期3年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for 复合聚醚醚酮界面螺钉 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20253130133 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.