Taiwan FDA registration ec382f32ffb7797b98b935076307cb8c

PixoTest blood Glucose Monitoring System

TW: 安必測血糖監測系統

Taiwan·Risk Class 2·MD·Inner Lake Plant of AXA Shengke Co., Ltd·Registered Aug 17, 2016 – Aug 17, 2021Expired

Registration details

Analysis ID: ec382f32ffb7797b98b935076307cb8c
License Form: Ministry of Health Medical Device Manufacturing No. 005341

Company information

Manufacturer: Inner Lake Plant of AXA Shengke Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: IXENSOR CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1345 Glucose Test System
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Aug 17, 2016
Expiry Date: Aug 17, 2021

About this record

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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