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PixoTest blood Glucose Monitoring System - Taiwan Registration ec382f32ffb7797b98b935076307cb8c

Access comprehensive regulatory information for PixoTest blood Glucose Monitoring System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ec382f32ffb7797b98b935076307cb8c and manufactured by Inner Lake Plant of AXA Shengke Co., Ltd. The authorized representative in Taiwan is IXENSOR CO., LTD..

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ec382f32ffb7797b98b935076307cb8c
Registration Details
Taiwan FDA Registration: ec382f32ffb7797b98b935076307cb8c
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Device Details

PixoTest blood Glucose Monitoring System
TW: ๅฎ‰ๅฟ…ๆธฌ่ก€็ณ–็›ฃๆธฌ็ณป็ตฑ
Risk Class 2
MD

Registration Details

ec382f32ffb7797b98b935076307cb8c

Ministry of Health Medical Device Manufacturing No. 005341

Company Information

Taiwan, Province of China

Product Details

This product can be used with Apple iPhone 5S/6/6 plus/6S/6S plus/SE and Samsung S6 smartphones installed with PixoHealth mobile application (APP), and can be used to detect the blood glucose concentration of fingertip microvascular whole blood in vitro. This product is designed for daily self-monitoring of blood sugar at home and should not be used to diagnose diabetes. This product is for personal use only and is not suitable for measuring the blood glucose of newborns.

A Clinical chemistry and clinical toxicology

A1345 Glucose Test System

Produced in Taiwan, China

Dates and Status

Aug 17, 2016

Aug 17, 2021