Hip Joint Prosthesis-Biological Type Femoral Stem
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253130019
- Approval date
- January 06, 2025
- Expiry date
- January 05, 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、北京市通州区通州经济开发区南区鑫隅三街 13 号
作为生物型假体，与同企业同一系统组件配合，适用于髋关节置换。
该产品由符合YY0117.1标准要求的钛合金材料制造，表面涂层采用ASTM F1580标准要求的纯钛涂层材料和符合GB23101.2标准要求的羟基磷灰石复合涂层制造。采用辐照灭菌包装，灭菌有效期5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Hip Joint Prosthesis-Biological Type Femoral Stem 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20253130019 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 06, 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.