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Electron lower gastrointestinal endoscopy - NMPA Registration 粤械注准20252060115

Access comprehensive regulatory information for Electron lower gastrointestinal endoscopy in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252060115 and owned by Sonoscape MEDICAL Corp.. The device was approved on January 23, 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 II
粤械注准20252060115
Electron lower gastrointestinal endoscopy
电子下消化道内窥镜
NMPA Registration Number: 粤械注准20252060115
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Intended Use
English

与本公司生产的图像处理装置配合使用,用于通过视频显示器提供影像供下消化道(包括肛门、直肠、结肠、回盲部)观察、诊断和治疗。

Device Classification
Device Class
Class II
Model Specifications
EC-650、EC-650L、EC-P650 、EC-P650L、EC-650T、EC-650TL
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20252060115
Approval Date
January 23, 2025
Expiry Date
January 22, 2030
Registrant
Name
Sonoscape MEDICAL Corp.
深圳开立生物医疗科技股份有限公司
Province/Region
Guangdong
广东
Address
深圳市南山区粤海街道麻岭社区高新中区科技中2路1号深圳软件园(2 期)12栋201、202
Production Facility
Production Address
深圳市光明区光明街道东周社区光明高新区东片区双明大道南侧二号路以西开立医疗大厦
Structure and Composition
English

由导光部、操作部、插入部、头端部及其附件组成,附件包括吸引阀、水气阀和钳道阀。

Additional Information
Appendix
产品技术要求