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Bioptik EasyTouch-mini (ET-1001)
Device Name:
EasyTouch-mini
Device Model:
ET-1001
Manufacturer:
Bioptik Technology Inc., 188 Jhonghua South Road, Jhunan Township, Miaoli County 35057, TAIWAN ROC.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Bioptik EasyTouch-mini (ET-1001) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Bioptik EasyTouch-mini (ET-1001), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG TÜV Rheinland Nederland General use Unpublished internal data