Taiwan FDA registration 3cae367dfc87e0d8e709cbff2f9711fc

Edfcon's blood glucose testing system

TW: 艾德福康血糖測試系統

Taiwan·Risk Class 2·BROADMASTER BIOTECH. CORP.·Registered Mar 21, 2022 – Mar 21, 2027Active

Registration details

Analysis ID: 3cae367dfc87e0d8e709cbff2f9711fc

Company information

Manufacturer: BROADMASTER BIOTECH. CORP.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BROADMASTER BIOTECH. CORP.

Product details

Intended Use: This product is used to measure the glucose content in fresh microvascular whole blood samples (from fingertips, palms, forearms, upper arms, calves and thighs). This product is suitable for home monitoring of blood glucose levels, or for professional measurement, but can not be used to diagnose diabetes, nor is it suitable for neonatal and arterial blood testing.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1345 Glucose Test System
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Mar 21, 2022
Expiry Date: Mar 21, 2027

About this record

Access comprehensive regulatory information for Edfcon's blood glucose testing system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3cae367dfc87e0d8e709cbff2f9711fc and manufactured by BROADMASTER BIOTECH. CORP.. The authorized representative in Taiwan is BROADMASTER BIOTECH. CORP..

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