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Orthopedic external fixation stents - NMPA Registration 闽械注准20242040227

Access comprehensive regulatory information for Orthopedic external fixation stents in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 闽械注准20242040227 and owned by Double Medical Technology Inc.. The device was approved on December 10, 2024.

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 II
闽械注准20242040227
Orthopedic external fixation stents
骨科外固定支架
NMPA Registration Number: 闽械注准20242040227
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Intended Use
English

连接体内骨针使用,通过牵拉骨端,实现骨折复位..

中文

连接体内骨针使用，通过牵拉骨端，实现骨折复位。.

Device Classification
Device Class
Class II
Approval Department
Fujian Provincial Drug Administration
福建省药品监督管理局
Registration Information
Registration Number
闽械注准20242040227
Approval Date
December 10, 2024
Expiry Date
December 09, 2029
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

骨科外固定支架根据不同结构型式分为手指牵引器、上肢牵引器、下肢牵引器;上肢牵引器与下肢牵引器由环、连接杆、撑开杆、骨牵引针夹、万向关节器、螺母组成.产品由不锈钢、铝合金及PEEK材料制成.产品经辐照灭菌,应无菌,一次性使用..

中文

骨科外固定支架根据不同结构型式分为手指牵引器、上肢牵引器、下肢牵引器；上肢牵引器与下肢牵引器由环、连接杆、撑开杆、骨牵引针夹、万向关节器、螺母组成。产品由不锈钢、铝合金及PEEK材料制成。产品经辐照灭菌，应无菌，一次性使用。.

Additional Information
Appendix
产品技术要求