Pure Global

Lock the bone plate system - NMPA Registration 国械注准20243130733

Access comprehensive regulatory information for Lock the 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20243130733 and owned by Henan Tuoren BEST MEDICAL Device Co., Ltd.. The device was approved on April 18, 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20243130733
Lock the bone plate system
锁定接骨板系统
NMPA Registration Number: 国械注准20243130733
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20243130733
Approval Date
April 18, 2024
Expiry Date
April 17, 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 product consists of a locking bone plate, a locking bone screw. Among them, the locking bone plate is made of TA3G pure titanium material in accordance with GB/T 13810 standard, and the locking bone screw is made of TC4ELI titanium alloy material in accordance with GB/T 13810 standard. The surface of the product is anodized with color, black and gray anodized or unanodized. Non-sterile supply.

中文

该产品由锁定接骨板、锁定接骨螺钉组成。其中锁定接骨板选用符合GB/T 13810标准规定的TA3G纯钛材料制造;锁定接骨螺钉选用符合GB/T 13810标准规定的TC4ELI钛合金材料制造。产品表面经着色阳极氧化、黑灰色阳极氧化或者未经阳极氧化处理。非无菌提供。

Additional Information
Appendix
产品技术要求