Taiwan FDA registration 15f588ba1277825a55b8b59bef89daed

Icegold Xinyou pen blood glucose monitoring system

TW: 愛思金鑫友筆型血糖監測系統
Taiwan flagTaiwan·Risk Class 2·Jinhong Medical Materials Technology Co., Ltd. Taoyuan Factory·Registered Nov 25, 2022 – Nov 25, 2027Active
Registration details
Analysis ID
15f588ba1277825a55b8b59bef89daed
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
This product is an in vitro diagnostic medical device, used to measure the blood glucose concentration in human fresh fingertip microvascular whole blood or venous whole blood in vitro, which can be used by professionals to conduct blood glucose test or self-blood glucose test for diabetic patients.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1345 Glucose Test System
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Nov 25, 2022
Expiry Date
Nov 25, 2027
About this record

Access comprehensive regulatory information for Icegold Xinyou pen 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 15f588ba1277825a55b8b59bef89daed and manufactured by Jinhong Medical Materials Technology Co., Ltd. Taoyuan Factory. The authorized representative in Taiwan is Jinhong Medical Materials Technology Co., Ltd. Taoyuan Factory.

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