Pure Global

Continuous Glucose Monitoring System - NMPA Registration 国械注准20243072505

Access comprehensive regulatory information for Continuous Glucose Monitoring System 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20243072505 and owned by Sinocare Inc.. The device was approved on December 13, 2024.

This page provides complete registration details including registrant information, province location (Hunan), 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20243072505
Continuous Glucose Monitoring System
持续葡萄糖监测系统
NMPA Registration Number: 国械注准20243072505
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

该产品配合持续葡萄糖监测系统应用程序(型号规格:iCGM-APP Pro、iCGM-APP;发布版本:02)、持续葡萄糖监测系统管理软件(发布版本:01)使用,可用于糖尿病成年患者(≥18岁)的组织液葡萄糖水平的连续或定期监测.该产品仅供单个用户在医疗机构使用,不需要用户校准,使用时间最长8天.该产品测量结果不作为决定和调整糖尿病患者治疗方案的依据.

中文

该产品配合持续葡萄糖监测系统应用程序(型号规格:iCGM-APP Pro、iCGM-APP;发布版本:02)、持续葡萄糖监测系统管理软件(发布版本:01)使用,可用于糖尿病成年患者(≥18岁)的组织液葡萄糖水平的连续或定期监测。该产品仅供单个用户在医疗机构使用,不需要用户校准,使用时间最长8天。该产品测量结果不作为决定和调整糖尿病患者治疗方案的依据。

Device Classification
Device Class
Class III
Model Specifications
H6,h6
H6,h6
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243072505
Approval Date
December 13, 2024
Expiry Date
December 12, 2029
Registrant
Name
Sinocare Inc.
三诺生物传感股份有限公司
Province/Region
Hunan
湖南
Address
No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone
长沙高新技术产业开发区谷苑路265号
Production Facility
Production Address
湖南省长沙市岳麓区青山西路11号
Structure and Composition
English

该产品由传感器套装(含探头)组成.

中文

该产品由传感器套装(含探头)组成。

Additional Information
Appendix
产品技术要求