Taiwan FDA registration e550658e6d3994fa06a17576c8793d04

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

TW: 糖立測多參數測試系統(血糖、紅血球容積比、酮體、總膽固醇、尿酸、血紅素)
Taiwan flagTaiwan·Risk Class 2·Taibo Technology Co., Ltd. five-stock factory·Registered Feb 06, 2024 – Jun 28, 2029Active
Registration details
Analysis ID
e550658e6d3994fa06a17576c8793d04
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
TAIDOC TECHNOLOGY CORPORATION
Product details
Intended Use
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.
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.1175 Cholesterol (Total) Testing System
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Feb 06, 2024
Expiry Date
Jun 28, 2029
About this record

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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