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单髁膝关节置换手术导航系统 - NMPA Registration 国械注准20253010072

Access comprehensive regulatory information for 单髁膝关节置换手术导航系统 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20253010072 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 10, 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.

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NMPA Official Data
Class III
国械注准20253010072
单髁膝关节置换手术导航系统
NMPA Registration Number: 国械注准20253010072
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Pricing
Intended Use
English

该产品与经验证的单髁膝关节假体联合使用,在成人单髁膝关节置换手术中用于手术工具和膝关节假体的导航。

Device Classification
Device Class
Class III
Model Specifications
黄河 INS-2
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253010072
Approval Date
January 10, 2025
Expiry Date
January 09, 2030
Registrant
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 Facility
Production Address
北京市通州区通州经济开发区南区鑫觅西二路10号
Structure and Composition
English

该产品由主控操作系统台车、光学追踪系统台车、脚踏开关、手持磨钻系统、手术器械工具包组成,详见产品技术要求。

Additional Information
Appendix
产品技术要求