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Glucose Measurement Multi-parameter Test System (Blood Glucose, Red Cell Volume, Ketones, Total Cholesterol, Uric Acid, Heme) - Taiwan Registration e550658e6d3994fa06a17576c8793d04

Access comprehensive regulatory information for Glucose Measurement Multi-parameter Test System (Blood Glucose, Red Cell Volume, Ketones, Total Cholesterol, Uric Acid, Heme) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e550658e6d3994fa06a17576c8793d04 and manufactured by Taibo Technology Co., Ltd. five-stock factory. The authorized representative in Taiwan is TAIDOC TECHNOLOGY CORPORATION.

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e550658e6d3994fa06a17576c8793d04
Registration Details
Taiwan FDA Registration: e550658e6d3994fa06a17576c8793d04
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Device Details

Glucose Measurement Multi-parameter Test System (Blood Glucose, Red Cell Volume, Ketones, Total Cholesterol, Uric Acid, Heme)
TW: ็ณ–็ซ‹ๆธฌๅคšๅƒๆ•ธๆธฌ่ฉฆ็ณป็ตฑ(่ก€็ณ–ใ€็ด…่ก€็ƒๅฎน็ฉๆฏ”ใ€้…ฎ้ซ”ใ€็ธฝ่†ฝๅ›บ้†‡ใ€ๅฐฟ้…ธใ€่ก€็ด…็ด )
Risk Class 2

Registration Details

e550658e6d3994fa06a17576c8793d04

Company Information

Taiwan, Province of China

Product Details

This product is an in vitro diagnostic medical device, which is used to quantitatively detect glucose, red blood cell volume ratio, ketone body, total cholesterol and uric acid content in the blood, and can also display the calculated value of heme. Glucose, red cell volume ratio, and ketone body measurements are done using fresh fingertip microvascular whole blood or venous whole blood. Total cholesterol and uric acid are measured using fresh fingerstick microvascular whole blood. It is provided for professional or personal self-testing and is not suitable for diagnosis and screening of diseases.

A Clinical chemistry and clinical toxicology

A.1775 Uric acid testing system;; A.1345 Glucose Test System;; A.1175 Cholesterol (Total) Testing System

QMS/QSD;; ๅœ‹็”ข

Dates and Status

Feb 06, 2024

Jun 28, 2029