Fora 6 Connect (GD82, BG50)
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.
|Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|TÜV SÜD (DE)||General use||Unpublished internal data|
|MDR Criteria||Self-measurement||Published evidence|
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