Continuous Glucose Monitoring System
- Device class
- Class III
- Model specifications
- H6,h6H6，h6
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243072505
- Approval date
- December 13, 2024
- Expiry date
- December 12, 2029
- 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 address
- 湖南省长沙市岳麓区青山西路11号
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.
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。
该产品由传感器套装(含探头)组成.
该产品由传感器套装(含探头)组成。
- Appendix
- 产品技术要求
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.