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Rapid glucose monitoring system - Taiwan Registration 820c0de70f4f3bce966a4166b350fa34

Access comprehensive regulatory information for Rapid 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 820c0de70f4f3bce966a4166b350fa34 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

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820c0de70f4f3bce966a4166b350fa34
Registration Details
Taiwan FDA Registration: 820c0de70f4f3bce966a4166b350fa34
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Device Details

Rapid glucose monitoring system
TW: ้€Ÿๅ€ๆธฌ่ก€็ณ–็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

820c0de70f4f3bce966a4166b350fa34

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.

I General, Plastic Surgery & Dermatology;; A Clinical Chemistry and Clinical Toxicology

I.4800 Manual instruments for general surgery; A.1345 Glucose Test System

QMS/QSD;; ๅœ‹็”ข

Dates and Status

Dec 10, 2020

Dec 10, 2025