Taiwan FDA registration fe58b18d32ebadcb682eecd3c1654f12

Speed Test New blood glucose/cholesterol/uric acid monitoring system

TW: 耐速測 全新 血糖/膽固醇/尿酸 監測系統
Taiwan flagTaiwan·Risk Class 2·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Jul 27, 2017 – Jul 27, 2027Active
Registration details
Analysis ID
fe58b18d32ebadcb682eecd3c1654f12
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
KERNEL INT'L CORP.
Product details
Intended Use
This product is only for in vitro testing, measured with fresh fingertip microvascular whole blood to quantify blood sugar, cholesterol and uric acid content, this product is only for professional use, but not suitable for neonatal testing.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1775 Uric acid testing system;; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System
Import Information
Domestic;; Contract manufacturing
Dates and status
Registration Date
Jul 27, 2017
Expiry Date
Jul 27, 2027
About this record

Access comprehensive regulatory information for Speed Test New blood glucose/cholesterol/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 fe58b18d32ebadcb682eecd3c1654f12 and manufactured by Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is KERNEL INT'L CORP..

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