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膝关节假体系统组件 - NMPA Registration 国械注准20253130176

Access comprehensive regulatory information for 膝关节假体系统组件 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20253130176 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20253130176
膝关节假体系统组件
NMPA Registration Number: 国械注准20253130176
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Pricing
Intended Use
English

The product works with the same system components of the company and is suitable for knee replacement.

中文

该产品与该企业同一系统组件配合,适用于膝关节置换。

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20253130176
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

该产品由胫骨衬垫组成。胫骨衬垫采用符合YY/T 0811标准规定的高交联超高分子量聚乙烯材料制成。产品灭菌包装,采用环氧乙烷灭菌,灭菌有效期5年。

Additional Information
Appendix
产品技术要求