Taiwan FDA registration ff967ad997405edd51ed0e1261448f43

Metrojet Multi-function Test System (Blood Glucose/Ketones/Total Cholesterol/Uric Acid)

TW: 百捷優善多功能檢驗系統(血糖/酮體/總膽固醇/尿酸)
Taiwan flagTaiwan·Risk Class 2·Qinli Biotechnology Co., Ltd. New North Plant·Registered Oct 14, 2021 – Oct 14, 2026Active
Registration details
Analysis ID
ff967ad997405edd51ed0e1261448f43
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
GENERAL LIFE BIOTECHNOLOGY CO., LTD.
Product details
Intended Use
This product is paired with a blood glucose test piece to detect the blood glucose concentration of whole blood/venous blood in the fingertips, palms or forearm microvessels. With Baijie ketone body test piece, Baijie Youshan total cholesterol test piece or Baijie Youshan uric acid test piece, ketone body, total cholesterol or uric acid concentration of fresh fingertip microvascular whole blood can be detected respectively. This product is suitable for home self-testing and professional detection of blood glucose, ketones, total cholesterol or uric acid concentration of fresh fingertip microvascular whole blood of patients. It is also suitable for professionals to measure the concentration of fresh venous blood glucose in patients, not for newborns. Efficacy: This product is paired with Platinum Blood Glucose Test Tablets, which can detect the blood glucose concentration of whole blood/venous blood in fingertips, palms or microvascular microvessels of the forearm. With ketone body test piece, total cholesterol test piece or uric acid test piece, ketone body, total cholesterol or uric acid concentration of fresh fingertip microvascular whole blood can be detected respectively. This product is suitable for home self-testing and professional detection of blood glucose, ketone bodies, total cholesterol or uric acid concentration of patients' fresh fingertip microvascular whole blood, and also suitable for professionals to detect the concentration of fresh venous blood glucose of patients. Not for use in 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.1175 Cholesterol (Total) Testing System
Import Information
國產;; QMS/QSD
Dates and status
Registration Date
Oct 14, 2021
Expiry Date
Oct 14, 2026
About this record

Access comprehensive regulatory information for Metrojet Multi-function Test System (Blood Glucose/Ketones/Total Cholesterol/Uric Acid) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ff967ad997405edd51ed0e1261448f43 and manufactured by Qinli Biotechnology Co., Ltd. New North Plant. The authorized representative in Taiwan is GENERAL LIFE BIOTECHNOLOGY CO., LTD..

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