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Gardack blood glucose monitoring system - Taiwan Registration 4703ffbbff9b083a4823d9997439d870

Access comprehensive regulatory information for Gardack 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 4703ffbbff9b083a4823d9997439d870 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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4703ffbbff9b083a4823d9997439d870
Registration Details
Taiwan FDA Registration: 4703ffbbff9b083a4823d9997439d870
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Device Details

Gardack blood glucose monitoring system
TW: ๅ˜‰้”ๅ…‹่ก€็ณ–็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

4703ffbbff9b083a4823d9997439d870

Company Information

Taiwan, Province of China

Product Details

This product is only for in vitro testing, quantitatively detecting the blood glucose value of fresh microvascular whole blood from fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh), and is not suitable for neonatal testing. This product can be used by professional medical professionals or diabetic patients to measure blood glucose levels, and is not intended as the final diagnosis of diabetes.

A Clinical chemistry and clinical toxicology

A.1345 Glucose Test System

ๅœ‹็”ข;; QMS/QSD

Dates and Status

Jul 15, 2021

Jul 15, 2026