Speed Test New blood glucose/cholesterol monitoring system - Taiwan Registration b162e3106d27e48744ee054b59846ff6
Access comprehensive regulatory information for Speed Test New blood glucose/cholesterol 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 b162e3106d27e48744ee054b59846ff6 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..
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Device Details
Product Details
The change of efficacy is: this product is only for in vitro testing, measured with fresh fingertip microvascular whole blood to quantify blood glucose and cholesterol content, this product can be used by self-tests and professionals, but not suitable for newborn testing.
A Clinical Chemistry and Clinical Toxicology;; I General, Plastic Surgery and Dermatology
I.4800 Manual instruments for general surgery; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System
Contract manufacturing;; Domestic
Dates and Status
Jun 01, 2018
Jun 01, 2028