Taiwan FDA registration 9bdaeb1c20b0f2f3c3f61faf15d9d9fd
Icegold Xinyou blood glucose monitoring system
TW: 愛思金鑫友血糖監測系統
Taiwan·Risk Class 2·Jinhong Medical Materials Technology Co., Ltd. Taoyuan Factory·Registered Dec 13, 2022 – Dec 13, 2027ActiveRegistration details
- Analysis ID
- 9bdaeb1c20b0f2f3c3f61faf15d9d9fd
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Ace Medical Technology Co., Ltd.
Product details
- Intended Use
- This product is an in vitro diagnostic medical device, used to quantitatively detect the glucose content in fresh fingertip microvascular whole blood or venous whole blood, fingertip microvascular whole blood is suitable for professionals and self-testing, venous blood is only for professional use, can not be used for diabetes diagnosis and screening.
- 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 13, 2022
- Expiry Date
- Dec 13, 2027
About this record
Access comprehensive regulatory information for Icegold Xinyou 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 9bdaeb1c20b0f2f3c3f61faf15d9d9fd and manufactured by Jinhong Medical Materials Technology Co., Ltd. Taoyuan Factory. The authorized representative in Taiwan is Ace Medical Technology Co., Ltd..
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