Taiwan FDA registration 7dec9ae6d337cf10b5d5587f9e567f06

Emetest Advanced Blood Glucose/Cholesterol/Uric Acid/Heme/Triglycerides Monitoring System

TW: 易美測進階型血糖/膽固醇/尿酸/血紅素/三酸甘油脂監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Mar 15, 2021 – Mar 15, 2026Expired

Registration details

Analysis ID: 7dec9ae6d337cf10b5d5587f9e567f06

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 glucose, cholesterol, uric acid, heme and triglycerides. 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.1775 Uric acid testing system;; A.1345 Glucose Test System;; A.1705 Triglyceride Test System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Mar 15, 2021
Expiry Date: Mar 15, 2026

About this record

Access comprehensive regulatory information for Emetest Advanced Blood Glucose/Cholesterol/Uric Acid/Heme/Triglycerides 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 7dec9ae6d337cf10b5d5587f9e567f06 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is BIOPTIK TECHNOLOGY, INC..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.