Bioptik EasySure-GCU (ET-3111)
Device Name:
EasySure-GCU
Device Model:
ET-3111
Manufacturer:
Bioptik Technology Inc., 188 Jhonghua South Road, Jhunan Township, Miaoli County 35057, TAIWAN ROC.
Measuring functions:
Blood glucose, Cholesterol and Uric Acid
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Bioptik EasySure-GCU (ET-3111) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Bioptik EasySure-GCU (ET-3111) to measure blood glucose.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | Not recommended | This device has not been clinically validated. |