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Medical endoscopic image processor - NMPA Registration 粤械注准20252060114

Access comprehensive regulatory information for Medical endoscopic image processor 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20252060114 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20252060114
Medical endoscopic image processor
医用内窥镜图像处理器
NMPA Registration Number: 粤械注准20252060114
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Pricing
Intended Use
English

配合本公司生产的医用电子内窥镜使用,用于将电子内窥镜采集到的图像进行处理后输送至显示器成像,并为电子内窥镜提供电源。

Device Classification
Device Class
Class II
Model Specifications
HD-650Exp、HD-650、HD-650Pro、HD-650Elite、HD-650S、HD-650Plus、HD-650Lite
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20252060114
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

由医用内窥镜图像处理器主机、电源线、键盘、调光电缆、光纤线缆、内镜电缆(选配)和脚踏开关(选配)组成。

Additional Information
Appendix
产品技术要求