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X-ray computed tomography equipment - NMPA Registration 国械注准20243061705

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20243061705 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on September 05, 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.

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Class III
国械注准20243061705
X-ray computed tomography equipment
X射线计算机体层摄影设备
NMPA Registration Number: 国械注准20243061705
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Intended Use
English

This product is used in routine clinical CT examinations and provides image data for radiation therapy plans.

中文

该产品用于常规临床CT检查,可为放射治疗计划提供图像数据。

Device Classification
Device Class
Class III
Model Specifications
XHCT-16iM
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243061705
Approval Date
September 05, 2024
Expiry Date
September 04, 2029
Registrant
Name
Shinva Medical Instrument Co., Ltd.
山东新华医疗器械股份有限公司
Province/Region
Shandong
山东
Address
Xinhua Medical Science and Technology Park, Zibo High-tech Industrial Development Zone, Shandong Province
山东省淄博市高新技术产业开发区新华医疗科技园
Production Facility
Production Address
淄博高新区齐祥路3588号
Structure and Composition
English

The product consists of a scanner, scanner, console, power cabinet, and options including a high-voltage generator, X-ray tube assembly, detector, collimator, console, console, and headrest.

中文

该产品由扫描架、扫描床、控制台、电源柜和选配件组成,其中扫描架包含高压发生器、X射线管组件、探测器、准直器,控制台含主机和显示器,选配件包括头部延长板和头托。

Additional Information
Appendix
产品技术要求