Taiwan FDA registration 9c5c1ae2d9cf2dd6efe722a6e13f39a4
Keyou blood glucose monitoring system
TW: 克優血糖監測系統
Taiwan·Risk Class 2·Ruiying Biomedical Technology Co., Ltd.;; Ruizhi Biochemical Technology Co., Ltd·Registered Dec 10, 2020 – Dec 10, 2025ExpiredRegistration details
- Analysis ID
- 9c5c1ae2d9cf2dd6efe722a6e13f39a4
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- AURUM BIOMEDICAL TECHNOLOGY, INC.
Product details
- Intended Use
- The Keyou Blood Glucose Monitoring System is used to quantify the blood glucose value of fresh microvascular whole blood, which can be used by patients for self-testing. It is for in vitro testing only, should not be used as a diagnosing tool for diabetes, and this system is not suitable for newborn testing.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- QMS/QSD;; 國產
Dates and status
- Registration Date
- Dec 10, 2020
- Expiry Date
- Dec 10, 2025
About this record
Access comprehensive regulatory information for Keyou blood 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 9c5c1ae2d9cf2dd6efe722a6e13f39a4 and manufactured by Ruiying Biomedical Technology Co., Ltd.;; Ruizhi Biochemical Technology Co., Ltd. The authorized representative in Taiwan is AURUM BIOMEDICAL TECHNOLOGY, INC..
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