Bioptik EasyMate-GCU (ET-311)
Device Name:
EasyMate-GCU
Device Model:
ET-311
Manufacturer:
Bioptik Technology Inc., 188 Jhonghua South Road, Jhunan Township, Miaoli County 35057, TAIWAN ROC.
Measuring functions:
Blood glucose, Uric Acid, Cholesterol
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Australia
Description:
The Bioptik EasyMate-GCU (ET-311) 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 EasyMate-GCU (ET-311) to measure blood glucose.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | Not recommended | This device has not been clinically validated. |