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Electrocautery Endoscope and Accessories - NMPA Registration 国械注准20253060237

Access comprehensive regulatory information for Electrocautery Endoscope and Accessories 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20253060237 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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NMPA Official Data
Class III
国械注准20253060237
Electrocautery Endoscope and Accessories
电切内窥镜及附件
NMPA Registration Number: 国械注准20253060237
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Intended Use
English

产品在医疗机构中,适用于前列腺、子宫或膀胱的检查,以及与等离子手术设备配合使用在生理盐水环境中对前列腺、子宫或膀胱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
MR PLASMA,组件型号见附页。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253060237
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
南京市江宁区经济技术开发区正方中路666号(委托生产)
Structure and Composition
English

由内窥镜、鞘套、操作器(含主动式工作手件、被动式工作手件、带通道工作手件)、等离子手术电极及其连接线和附件组成。

Additional Information
Remark
受托生产企业:南京迈瑞生物医疗电子有限公司;统一社会信用代码:913201157937318730
Appendix
产品技术要求