Taiwan FDA registration 7bf22c62fca807330ec1ac8abef5c1b0
Rett Active Continuous Glucose Monitoring System
TW: 瑞特安活連續葡萄糖監測系統
Taiwan·Risk Class 2·Daqing Factory of Huaguang Biotechnology Co., Ltd·Registered Oct 06, 2023 – Oct 06, 2028ActiveRegistration details
- Analysis ID
- 7bf22c62fca807330ec1ac8abef5c1b0
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Daqing Factory of Huaguang Biotechnology Co., Ltd
Product details
- Intended Use
- The Continuous Glucose Monitoring System (this product) is suitable for users aged 18 to 80 who need blood glucose management, this product can continuously detect the glucose concentration of the user's interstitial fluid, assist the user to observe the trend of glucose changes, and replace the blood glucose measurement of fingerstick blood collection. This product also assists in the detection of hyperglycemia and hypoglycemia events, and serves as a reference for acute and long-term treatment. The results of this product should be interpreted based on both glucose trends and continuous readings.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1355 Integrated Continuous Glucose Monitoring System
- Import Information
- QMS/QSD;; 國產
Dates and status
- Registration Date
- Oct 06, 2023
- Expiry Date
- Oct 06, 2028
About this record
Access comprehensive regulatory information for Rett Active Continuous Glucose Monitoring System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7bf22c62fca807330ec1ac8abef5c1b0 and manufactured by Daqing Factory of Huaguang Biotechnology Co., Ltd. The authorized representative in Taiwan is Daqing Factory of Huaguang Biotechnology Co., Ltd.
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