Single-use plasma surgical electrodes
- Device class
- Class III
- Model specifications
- X E302605L、X E302609L、X E30260BL、X E302605M、X E302609M、X E30260BM、X E302609R、X E30260BR、X E302609V、X E302605N、X O302609L、X O302609M、X O302609R、X O302605N
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253010233
- Approval date
- January 24, 2025
- Expiry date
- January 23, 2030
- Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.深圳迈瑞生物医疗电子股份有限公司
- Province/Region
- Guangdong广东
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen深圳市南山区高新技术产业园区科技南十二路迈瑞大厦1-4层
- Production address
- 浙江省杭州市桐庐县桐庐经济开发区凤翔路2号（委托生产）
产品在医疗机构中，与电切内窥镜和等离子手术设备配合使用，在生理盐水环境下，对前列腺、膀胱或宫腔组织进行切割和凝血；与本公司生产的超声高频集成手术设备(型号：UP703、UP705、 UP710、UP713、UP715、UP Platinum)的等离子功能配合使用，还可对前列腺、膀胱或宫腔组织进行汽化。
产品由工作端、电极轴（含绝缘管、金属管）、稳定管以及插接端子组成。
- Remark
- 受托生产企业：杭州迈瑞医疗科技有限公司；统一社会信用代码：91330122720041150R。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Single-use plasma surgical electrodes 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20253010233 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was approved on January 24, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.