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Speed Test New blood glucose/uric acid monitoring system - Taiwan Registration 7170c19ce391511c1e784f3c3c6f97e0

Access comprehensive regulatory information for Speed Test New blood glucose/uric acid 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 7170c19ce391511c1e784f3c3c6f97e0 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..

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7170c19ce391511c1e784f3c3c6f97e0
Registration Details
Taiwan FDA Registration: 7170c19ce391511c1e784f3c3c6f97e0
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Device Details

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

Registration Details

7170c19ce391511c1e784f3c3c6f97e0

Company Information

Taiwan, Province of China

Product Details

This product is only for in vitro testing to quantitatively measure blood glucose and uric acid levels using fresh fingertip microvascular whole blood. This product is intended for self-testing and professional use, but is not intended for testing in newborns.

A Clinical chemistry and clinical toxicology

A.1775 Uric acid testing system;; A.1345 Glucose Test System

Contract manufacturing;; Domestic

Dates and Status

Jun 14, 2018

Jun 14, 2028