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Endoscopic camera system - NMPA Registration 粤械注准20242061261

Access comprehensive regulatory information for Endoscopic camera system 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20242061261 and owned by Edan Instruments, Inc.. The device was approved on September 26, 2024.

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20242061261
Endoscopic camera system
内窥镜摄像系统
NMPA Registration Number: 粤械注准20242061261
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Intended Use
English

Intended for use with medical endoscopes, suitable for providing real-time visible light images in minimally invasive endoscopic surgery; It is expected to be used in conjunction with medical endoscopes and fluorescent contrast agent indocyanine green (ICG), which is suitable for providing real-time visible light images and near-infrared fluorescence images in minimally invasive endoscopic surgery.

中文

预期与医用内窥镜配合使用,适用于在微创内窥镜手术中提供实时的可见光影像;预期与医用内窥镜、荧光造影剂吲哚菁绿(ICG)配合使用,适用于在微创内窥镜手术中提供实时的可见光影像及近红外荧光影像。

Device Classification
Device Class
Class II
Model Specifications
UE30、UE60、UE56R、UE80R、UE90R、UE30、UE56、UE60、UE58、UE59、UE90、Fe30、Fe56、Fe60、Fe90
UE30R、UE60R、UE56R、UE80R、UE90R、UE30、UE56、UE60、UE58、UE59、UE80、UE90、FE30、FE56、FE60、FE90
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242061261
Approval Date
September 26, 2024
Expiry Date
September 25, 2029
Registrant
Name
Edan Instruments, Inc.
深圳市理邦精密仪器股份有限公司
Province/Region
Guangdong
广东
Address
No. 15, Jinhui Road, Jinsha Community, Kengzi Street, Pingshan New District, Shenzhen
深圳市坪山新区坑梓街道金沙社区金辉路15号
Production Facility
Production Address
深圳市坪山新区坑梓街道金沙社区金辉路15号
Structure and Composition
English

The endoscope camera system consists of a camera unit, a camera, cables (power cables, signal cables), and a foot switch (optional).

中文

内窥镜摄像系统由摄像主机、摄像头、电缆线(电源线、信号线)、脚踏开关(选配)组成。

Additional Information
Appendix
产品技术要求