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Fora Comfort Plus (G30a)
Device Name:
Fora Fora Comfort Plus
Device Model:
G30, G30a, TD-4241A
Manufacturer:
Puyang Technology Co. Ltd. (ForaCare), 1st Floor, 127 Wugong 2nd Road, Wugu District 24888, New Taipei City, TAIWAN ROC.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United Arab Emirates, Switzerland, Taiwan ROC and United States
Device Manual:
Description:
The Fora Comfort Plus (G30a) 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 normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
While the technology used in the Fora Comfort Plus (G30a), 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BG TÜV SÜD (DE) General use Unpublished internal data
BG Institute of Health Economics (CA) General use No evidence provided