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一次性骨水泥注入套件 - NMPA Registration 闽械注准20242040222

Access comprehensive regulatory information for 一次性骨水泥注入套件 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20242040222 and owned by Double Medical Technology Inc.. The device was approved on November 29, 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20242040222
一次性骨水泥注入套件
NMPA Registration Number: 闽械注准20242040222
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Pricing
Intended Use
English

适用于脊柱内固定术中,建立工作通道,将骨水泥注入(输送到)需填充部位.

中文

适用于脊柱内固定术中,建立工作通道,将骨水泥注入(输送到)需填充部位.

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20242040222
Approval Date
November 29, 2024
Expiry Date
November 28, 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

产品由一次性骨水泥注入套管、推杆组成.采用05Cr17Ni4Cu4Nb不锈钢材料制成.采用环氧乙烷灭菌..

中文

产品由一次性骨水泥注入套管、推杆组成。采用05Cr17Ni4Cu4Nb不锈钢材料制成。采用环氧乙烷灭菌。.

Additional Information
Appendix
产品技术要求