Taiwan FDA registration b385484ff1f8fc8741622365ffa94fc3

Yilitest transmission type blood glucose/cholesterol/uric acid multi-function monitoring system

TW: 易立測傳輸型血糖/膽固醇/尿酸多功能監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Nov 13, 2014 – Nov 13, 2029Active

Registration details

Analysis ID: b385484ff1f8fc8741622365ffa94fc3

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BIOPTIK TECHNOLOGY, INC.

Product details

Intended Use: This product is for in vitro testing only, measured with fresh fingertip microvascular whole blood to quantify blood sugar, cholesterol and uric acid. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1175 Cholesterol (Total) Test System;; A.1345 Glucose Test System;; A.1775 Uric acid testing system
Import Information: Domestic

Dates and status

Registration Date: Nov 13, 2014
Expiry Date: Nov 13, 2029

About this record

Access comprehensive regulatory information for Yilitest transmission type blood glucose/cholesterol/uric acid multi-function 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 b385484ff1f8fc8741622365ffa94fc3 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is BIOPTIK TECHNOLOGY, INC..

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