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EKang Multifunctional monitoring system for blood glucose/cholesterol/heme - Taiwan Registration 7275da14a25adb1eafc569a7db8f3acb

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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7275da14a25adb1eafc569a7db8f3acb
Registration Details
Taiwan FDA Registration: 7275da14a25adb1eafc569a7db8f3acb
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Device Details

EKang Multifunctional monitoring system for blood glucose/cholesterol/heme
TW: ๆ˜“ๅบท ่ก€็ณ–/่†ฝๅ›บ้†‡/่ก€็ด…็ด ๅคšๅŠŸ่ƒฝ็›ฃๆธฌ็ณป็ตฑ
Risk Class 2

Registration Details

7275da14a25adb1eafc569a7db8f3acb

Company Information

Taiwan, Province of China

Product Details

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.

B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology

A.1345 Glucose Test System;; B.7500 Heme analysis of whole blood;; A.1175 Cholesterol (Total) Testing System

Contract manufacturing;; Domestic

Dates and Status

Apr 09, 2013

Jun 13, 2026