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Arkray Glucocard 01-Mini (GT-1941)
Device Name:
Glucocard 01-Mini
Device Model:
GT-1941
Manufacturer:
Arkray Global Business Inc., 1408 Koji, Konan cho, koka shi, Shiga, JAPAN.
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 Arkray Glucocard 01-Mini (GT-1941) 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 Arkray Glucocard 01-Mini (GT-1941), 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