Taiwan FDA registration 94f4402de86b322fdf8fee83119cb531

Rhett blood glucose ketone monitoring system

TW: 瑞特血糖血酮監測系統
Taiwan flagTaiwan·Risk Class 2·Daqing Factory of Huaguang Biotechnology Co., Ltd·Registered May 04, 2023 – May 04, 2028Active
Registration details
Analysis ID
94f4402de86b322fdf8fee83119cb531
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
Rite blood glucose ketone monitoring system is specially designed for in vitro diagnosis, for users to self-measure the blood glucose value of fingertips, palms or arms whole blood or professionals to measure the blood glucose values of microvascular whole blood and venous, arterial, neonatal whole blood collected by others' fingertips, palms or arms, and can also be used by users or professionals to measure fingertip microvascular blood ketone values.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1435 Ketone (non-quantitative) testing system;; A.1345 Glucose Test System
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
May 04, 2023
Expiry Date
May 04, 2028
About this record

Access comprehensive regulatory information for Rhett blood glucose ketone 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 94f4402de86b322fdf8fee83119cb531 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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