China NMPA legacy archive 国械注准20243072511Continuous Glucose Monitoring System
持续葡萄糖监测系统
Sinocare Inc.Class IIINMPAApproved December 13, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- i6、i6s、i6Pro
- Approval department
- State Drug Administration
国家药品监督管理局
Registration information
- Registration number
- 国械注准20243072511
- Approval date
- December 13, 2024
- Expiry date
- December 12, 2029
Registrant
- Province/Region
- Hunan
- Address
- No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone
湖南
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
Intended use
English
该产品配合持续葡萄糖监测系统应用程序(iCGM-APP,发布版本02)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,仅供单个用户在家庭环境使用,不需要用户校准,使用时间最长15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（iCGM-APP，发布版本02）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，仅供单个用户在家庭环境使用，不需要用户校准，使用时间最长15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。
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
About this record
This static archive preserves historical registration fields and translations for Continuous Glucose Monitoring System, registration 国械注准20243072511. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.