Medical electron linear accelerator
- Device class
- Class III
- Model specifications
- XHA600F
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243050900
- Approval date
- May 14, 2024
- Expiry date
- May 13, 2029
- 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 address
- 淄博高新区齐祥路3588号
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。
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。
- Appendix
- 产品技术要求
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.