Taiwan FDA registration 5639a43aab8f72dbf8b0ae645733a672

Good Test Blood Glucose Test Kit

TW: 良測肆號血糖測試套組
Taiwan flagTaiwan·Risk Class 2·TYSON BIORESEARCH INC.·Registered Jan 31, 2024 – Jan 31, 2029Active
Registration details
Analysis ID
5639a43aab8f72dbf8b0ae645733a672
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
TYSON BIORESEARCH INC.
Product details
Intended Use
This product is designed for in vitro diagnostics and can be used by professionals to measure blood glucose values through microvascular whole blood and venous whole blood collected from fingertips, palms or forearms. It can also be used for self-measurement of blood glucose levels on fingertips, palms or forearms of the general public (for single use only). Not suitable for newborns. This system should not be used as a diagnostic screening tool for diabetes. When there is a large fluctuation in blood glucose values, it is not advisable to use alternative sites as a source of blood collection. The Liangsey Blood Glucose Test Tablet can only be used with the Liangsey Blood Glucose Device (Model: JS100/ JS100-B/ JS200/ JS200-B).
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
Jan 31, 2024
Expiry Date
Jan 31, 2029
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About this record

Access comprehensive regulatory information for Good Test Blood Glucose Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5639a43aab8f72dbf8b0ae645733a672 and manufactured by TYSON BIORESEARCH INC.. The authorized representative in Taiwan is TYSON BIORESEARCH INC..

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