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Medical electron linear accelerator - NMPA Registration 国械注准20243050900

Access comprehensive regulatory information for Medical electron linear accelerator 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20243050900 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on May 14, 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20243050900
Medical electron linear accelerator
医用电子直线加速器
NMPA Registration Number: 国械注准20243050900
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Pricing
Intended Use
English

该产品临床适用于对人体适合接受放射治疗的肿瘤病灶提供放射治疗,具体适应症由具有资质的临床医生根据实际情况确定。

Device Classification
Device Class
Class III
Model Specifications
XHA600F
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243050900
Approval Date
May 14, 2024
Expiry Date
May 13, 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

该产品由控制台、机架、治疗床、楔形过滤器和多叶准直器组成。

Additional Information
Appendix
产品技术要求