Taiwan FDA registration 3eb266950c3b2b00b8e3e92cbd38600c

Melif blood glucose monitoring system

TW: 邁萊弗血糖監測系統

Taiwan·Risk Class 2·Daqing Factory of Huaguang Biotechnology Co., Ltd·Registered May 10, 2023 – May 10, 2028Active

Registration details

Analysis ID: 3eb266950c3b2b00b8e3e92cbd38600c

Company information

Manufacturer: Daqing Factory of Huaguang Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Daqing Factory of Huaguang Biotechnology Co., Ltd

Product details

Intended Use: The blood glucose machine in the Myrefer Blood Glucose Monitoring System (Pura) must be equipped with the corresponding model of blood glucose test piece, which is designed by the in vitro diagnostic institute and can be used by professionals and diabetic patients to self-measure the blood glucose value in the whole blood of the fingertips, palms or microvascular blood vessels of the arm. The Unio/ Unio Neva/ Unio Cara is specially designed for in vitro diagnostics, which can be used by professionals to measure the blood glucose value of microvascular whole blood and venous, arterial and neonatal whole blood collected through the fingertips, palms or arms, and can also be used for diabetic patients to self-measure the blood glucose values of fingertips, palms or arm microvascular whole blood.
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: May 10, 2023
Expiry Date: May 10, 2028

About this record

Access comprehensive regulatory information for Melif 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 3eb266950c3b2b00b8e3e92cbd38600c and manufactured by Daqing Factory of Huaguang Biotechnology Co., Ltd. The authorized representative in Taiwan is Daqing Factory of Huaguang Biotechnology Co., Ltd.

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