Speed Test New blood glucose/heme monitoring system - Taiwan Registration ef3c3ed9f8e4651f7c9f7734b9ce5500
Access comprehensive regulatory information for Speed Test New blood glucose/heme 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 ef3c3ed9f8e4651f7c9f7734b9ce5500 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..
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Device Details
Product Details
This product is only for in vitro testing, and the blood glucose and heme content are quantitatively detected by fresh fingertip microvascular whole blood. This product can be used by self-testing and professionals, but is not intended for testing of newborns.
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
A.1345 Glucose Test System;; B.7500 Heme analysis of whole blood
Domestic;; Contract manufacturing
Dates and Status
Jun 14, 2018
Jun 14, 2028