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BeneCheck Premium-GLU
Device Name:
Premium-GLU
Manufacturer:
General Life Biotechnology Co. Ltd. (BeneCheck), 6F No. 272-1 Xinshu Road, Xinzhuang District, New Taipei City 242, TAIWAN ROC.
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The BeneCheck Premium-GLU 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 BeneCheck Premium-GLU, 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 Institute of Health Economics (CA) General use No evidence provided