Taiwan FDA registration 2b6771be294166492b0737b5e27ed803

Speed Test New blood glucose/cholesterol/heme monitoring system

TW: 耐速測全新血糖/膽固醇/血紅素監測系統

Taiwan·Risk Class 2·Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd·Registered Feb 22, 2017 – Feb 22, 2027Active

Registration details

Analysis ID: 2b6771be294166492b0737b5e27ed803

Company information

Manufacturer: Nine Feather International Enterprises Limited;; Yuxin Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: KERNEL INT'L CORP.

Product details

Intended Use: This product is for in vitro testing only, measuring blood sugar, cholesterol and heme content with fresh fingertip microvascular whole blood. This product is for self-testing only (for single use), but not for testing newborns.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System;; B.7500 Heme analysis of whole blood;; A.1175 Cholesterol (Total) Testing System
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Feb 22, 2017
Expiry Date: Feb 22, 2027

About this record

Access comprehensive regulatory information for Speed Test New blood glucose/cholesterol/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 2b6771be294166492b0737b5e27ed803 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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