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Hip Joint Prosthesis-Biological Type Femoral Stem - NMPA Registration 国械注准20253130019

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.

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NMPA Official Data
Class III
国械注准20253130019
Hip Joint Prosthesis-Biological Type Femoral Stem
髋关节假体-生物型股骨柄
NMPA Registration Number: 国械注准20253130019
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Pricing
Intended Use
English

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。

Device Classification
Device Class
Class III
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253130019
Approval Date
January 06, 2025
Expiry Date
January 05, 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、北京市通州区通州经济开发区南区鑫隅三街 13 号
Structure and Composition
English

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。

Additional Information
Appendix
产品技术要求