Steady Blood Glucose Monitoring System - Taiwan Registration 41f9eb919a7fcfcfffb36ab0348bd06f
Access comprehensive regulatory information for Steady 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 41f9eb919a7fcfcfffb36ab0348bd06f and manufactured by Flextronics Industrial (Shenzhen) Co., Ltd;; LifeScan Europe GmbH. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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Device Details
Registration Details
41f9eb919a7fcfcfffb36ab0348bd06f
DHA09200128109
Product Details
Used to quantitatively measure glucose (blood glucose) in fresh microvascular whole blood samples taken from fingertips. This system is intended for use by a single patient only and should not be shared. The system is designed to provide in vitro measurement of blood glucose concentrations in the home of diabetics (for in vitro diagnostics) and can also be used by healthcare professionals in clinical settings to assist in monitoring the effectiveness of diabetes control. This system is not intended for the diagnosis or screening of diabetes, nor is it intended for use in newborns.
A Clinical chemistry and clinical toxicology
A.1345 Glucose Test System
Input;; QMS/QSD;; Chinese goods;; Contract manufacturing
Dates and Status
Aug 24, 2021
Feb 02, 2028