Adjustable Loop Titanium Plate
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130130
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
- Name
- Beijing Chunlizhengda Medical Instruments Co., Ltd.北京市春立正达医疗器械股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 10, Xinmi West 2nd Road, South District, Tongzhou Economic Development Zone, Tongzhou District, Beijing北京市通州区通州经济开发区南区鑫觅西二路10号
- Production address
- 北京市通州区通州经济开发区南区鑫觅西二路10号
本产品适用于膝关节交叉韧带重建术中软组织与骨的固定。
可调节带袢钛板产品由线圈、牵引线、翻袢线、钛板组成。其中钛板均采用符合GB/T13810标准的TC4材料制造，钛板表面无着色或经着色阳极氧化处理；线圈、牵引线、翻袢线的材质采用符合YY/T1431的超高分子聚乙烯（UHMWPE）材料制造，线圈为白色，牵引线为蓝白色，翻袢线为蓝色，蓝色染料为符合21CFR73.1015的钴铬蓝。牵引线只起导引作用，翻袢线只起翻转钛板作用，牵引线、翻袢线不得用于植入。产品经环氧乙烷灭菌，无菌包装，有效期为5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Adjustable Loop Titanium Plate 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20253130130 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Beijing), 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.