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Hip prosthesis Double-action acetabular lining - NMPA Registration 国械注准20253130152

Access comprehensive regulatory information for Hip prosthesis Double-action acetabular lining 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20253130152 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.

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Class III
国械注准20253130152
Hip prosthesis Double-action acetabular lining
髋关节假体 双动髋臼内衬
NMPA Registration Number: 国械注准20253130152
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Pricing
Intended Use
English

Works with the same system components as the enterprise for hip replacement.

中文

与该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20253130152
Approval Date
January 20, 2025
Expiry Date
January 19, 2030
Registrant
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 Facility
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
Structure and Composition
English

该产品由双动内衬组成,双动内衬采用符合ASTM F2695标准的含维生素E的高交联超高分子量聚乙烯材料制成;产品采用环氧乙烷灭菌包装,灭菌有效期5年。

Additional Information
Appendix
产品技术要求