Pure Global

X-ray computed tomography equipment - NMPA Registration 国械注准20243061741

Access comprehensive regulatory information for X-ray computed tomography equipment 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20243061741 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on September 12, 2024.

This page provides complete registration details including registrant information, province location (Shandong), 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20243061741
X-ray computed tomography equipment
X射线计算机体层摄影设备
NMPA Registration Number: 国械注准20243061741
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

This product is used for routine clinical CT examination.

中文

本产品用于常规临床CT检查。

Device Classification
Device Class
Class III
Model Specifications
ZS-CT51-A
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243061741
Approval Date
September 12, 2024
Expiry Date
September 11, 2029
Registrant
Name
Shandong Zhushi Pharmaceutical Group Co., Ltd.
山东朱氏药业集团有限公司
Province/Region
Shandong
山东
Address
South of Fanlou Road, Shanxian Development Zone
单县开发区樊楼路南
Production Facility
Production Address
山东单县经济技术开发区食品药品产业园单德路6号
Structure and Composition
English

X-ray computed tomography equipment consists of a scanner (containing X-ray tube assembly, high-voltage generator, detector), patient stand, console assembly (workstation, monitor, scan control box, patient intercom system), power adapter, accessories, and foot switch (optional).

中文

X射线计算机体层摄影设备由扫描架(包含X射线管组件、高压发生器、探测器)、患者支架、控制台组件(工作站、显示器、扫描控制盒、患者对讲系统)、电源适配器、附件和脚踏开关(选配)组成。

Additional Information
Appendix
产品技术要求