Taiwan FDA registration 7275da14a25adb1eafc569a7db8f3acb

EKang Multifunctional monitoring system for blood glucose/cholesterol/heme

TW: 易康血糖/膽固醇/血紅素多功能監測系統

Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Apr 09, 2013 – Jun 13, 2026Expired

Registration details

Analysis ID: 7275da14a25adb1eafc569a7db8f3acb

Company information

Manufacturer: BIOPTIK TECHNOLOGY, INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: EASY LIFE GREEN TECHNOLOGY CORPORATION

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 heme content. This product can be used by self-testing and healthcare professionals, but is not intended for testing of newborns. The efficacy has been changed to: This product is only for in vitro testing, and the blood glucose and heme content are quantified by measuring fresh fingertip microvascular whole blood. This product is intended for professional use only, but is not intended for testing of 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: Contract manufacturing;; Domestic

Dates and status

Registration Date: Apr 09, 2013
Expiry Date: Jun 13, 2026

About this record

Access comprehensive regulatory information for EKang Multifunctional monitoring system for blood glucose/cholesterol/heme in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7275da14a25adb1eafc569a7db8f3acb and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is EASY LIFE GREEN TECHNOLOGY CORPORATION.

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