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Carbon dioxide aeration device for endoscopes - NMPA Registration 粤械注准20242061168

Access comprehensive regulatory information for Carbon dioxide aeration device for endoscopes 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20242061168 and owned by Sonoscape MEDICAL Corp.. The device was approved on September 04, 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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NMPA Official Data
Class II
粤械注准20242061168
Carbon dioxide aeration device for endoscopes
内窥镜用二氧化碳送气装置
NMPA Registration Number: 粤械注准20242061168
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Intended Use
English

It is used to inject carbon dioxide gas into the upper and lower digestive tracts during endoscopic diagnosis and/or treatment/surgery.

中文

用于在内窥镜诊断和/或治疗/手术中向上、下消化道注入二氧化碳气体。

Device Classification
Device Class
Class II
Model Specifications
SCP-1
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242061168
Approval Date
September 04, 2024
Expiry Date
September 03, 2029
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
Shenzhen Software Park (Phase 2), Building 12, 201, 202, No. 1, Keji Middle Road, High-tech Middle District, Maling Community, Yuehai Street, Nanshan District, Shenzhen
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

The product consists of a main engine and an air supply pipe, and its optional accessories are: air intake pipe and foot switch.

中文

产品由主机和送气管组成,其可选配件为:进气管和脚踏开关。

Additional Information
Appendix
产品技术要求