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Fora 6 Plus (GD81)
Device Name:
Fora 6 Plus
Device Model:
GD81
Manufacturer:
Puyang Technology Co. Ltd. (ForaCare), 1st Floor, 127 Wugong 2nd Road, Wugu District 24888, New Taipei City, TAIWAN ROC.
Measuring functions:
Blood glucose, Hematocrit, Haemoglobin, β-Ketones, Uric Acid, Total Cholesterol
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
USB
Availability:
Available Currently
Availability according to Countries or Regions:
United Arab Emirates and Switzerland
Description:
The Fora 6 Plus (GD81) 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 Fora 6 Plus (GD81), 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BG TÜV Rheinland Nederland General use Unpublished internal data
BG TÜV SÜD (DE) General use Unpublished internal data