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Fora 6 Connect (GD82, BG50)

Device Name:Fora 6 Connect
Device Model:GD82, BG50
Manufacturer:Puyang Technology Co. Ltd. (ForaCare), 1st Floor, 127 Wugong 2nd Road, Wugu District 24888, New Taipei City, TAIWAN PRC.
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
Availability:Available Currently
Description: The Fora 6 Connect (GD82, BG50) is a clinically validated and 2-star blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

The technology used in the Fora 6 Connect (GD82, BG50), to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
TÜV SÜD (DE)General useUnpublished internal data
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Jendrike N, Baumstark A, Pleus S, Mende J, Haug C, Freckmann G. Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197. J Diabetes Sci Technol. 2019 Mar;13(2):235-241. Epub: 2018 Dec 14. doi: 101177/1932296818821105. PMID: 30547683. Available from: PMC6399804.

15197:2013 - Pass General population