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Speed Test New blood glucose monitoring system - Taiwan Registration 109b9f057199060e612186056225de9c

Access comprehensive regulatory information for Speed Test New 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 109b9f057199060e612186056225de9c and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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109b9f057199060e612186056225de9c
Registration Details
Taiwan FDA Registration: 109b9f057199060e612186056225de9c
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Device Details

Speed Test New blood glucose monitoring system
TW: ่€้€Ÿๆธฌ ๅ…จๆ–ฐ ่ก€็ณ–็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

109b9f057199060e612186056225de9c

Company Information

Taiwan, Province of China

Product Details

This product is for in vitro testing only, measuring blood glucose levels with fresh fingertip microvascular whole blood. This product can be used by self-testing and professionals, but is not intended for testing of newborns.

A Clinical chemistry and clinical toxicology

A.1345 Glucose Test System

Domestic;; Contract manufacturing

Dates and Status

Jul 20, 2018

Jul 20, 2028