Taiwan FDA registration f1714d6f5d775faecfad0756abba8553

GlucoLeader Blood Glucose Test Strip

TW: 測利得血糖檢測試片
Taiwan flagTaiwan·Risk Class 2·MD·HMD BIOMEDICAL INC.·Registered Aug 09, 2017 – Aug 09, 2027Active
Registration details
Analysis ID
f1714d6f5d775faecfad0756abba8553
License Form
Ministry of Health Medical Device Manufacturing No. 005634
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
HMD BIOMEDICAL INC.
Product details
Intended Use
GLH can only be used with the Enhance2 blood glucose meter. Provide diabetic patients with home detection of microvascular whole blood glucose values. And under the operation of professional nursing staff in the hospital, the blood glucose value of adult microvascular whole blood and venous blood can be tested. Not applicable to blood glucose testing for newborn infants.
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 09, 2017
Expiry Date
Aug 09, 2027
About this record

Access comprehensive regulatory information for GlucoLeader Blood Glucose Test Strip in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f1714d6f5d775faecfad0756abba8553 and manufactured by HMD BIOMEDICAL INC.. The authorized representative in Taiwan is HMD BIOMEDICAL INC..

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