Pure Global

Non-locking metal bone plate system - NMPA Registration 国械注准20243131242

Access comprehensive regulatory information for Non-locking metal bone plate system 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20243131242 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on July 10, 2024.

This page provides complete registration details including registrant information, province location (Henan), 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20243131242
Non-locking metal bone plate system
非锁定金属接骨板系统
NMPA Registration Number: 国械注准20243131242
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

Suitable for internal fixation of limb fractures.

中文

适用于四肢骨折内固定。

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20243131242
Approval Date
July 10, 2024
Expiry Date
July 09, 2029
Registrant
Name
Henan Tuoren BEST MEDICAL Device Co., Ltd.
河南驼人贝斯特医疗器械有限公司
Province/Region
Henan
河南
Address
Changyuan City Nanpu Street Office Weiqi Road Middle Road South
长垣市南蒲街道办事处纬七路中段路南
Production Facility
Production Address
长垣市南蒲街道办事处纬七路中段路南
Structure and Composition
English

The non-locking metal plate system includes non-locking plates and non-locking screws. The bone plate is made of TA3G pure titanium material in accordance with the GB/T 13810 standard, and the bone screw is made of TC4ELI titanium alloy material in accordance with the GB/T 13810 standard. The surface of the product is anodized with black and gray color. Non-sterile supply.

中文

非锁定金属接骨板系统包括非锁定接骨板和非锁定接骨螺钉。接骨板选用符合GB/T 13810标准规定的TA3G纯钛材料制造,接骨螺钉选用符合GB/T 13810标准规定的TC4ELI钛合金材料制造。产品表面经黑灰色阳极氧化处理。非无菌提供。

Additional Information
Appendix
产品技术要求