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Single-use plasma surgical electrodes - NMPA Registration 国械注准20253010233

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.

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Class III
国械注准20253010233
Single-use plasma surgical electrodes
一次性使用等离子手术电极
NMPA Registration Number: 国械注准20253010233
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Pricing
Intended Use
English

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。

Device Classification
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 Information
Registration Number
国械注准20253010233
Approval Date
January 24, 2025
Expiry Date
January 23, 2030
Registrant
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 Facility
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)
Structure and Composition
English

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。

Additional Information
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