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Foracare Comfort Pro (GD40b)

Device Name:Comfort Pro
Device Model:GD40b
Manufacturer:ForaCare Suisse AG, Neugasse 55, CH-9000 St. Gallen, SWITZERLAND.
Measuring functions:Blood glucose
Primary Client Use:Intended for professional use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Foracare Comfort Pro (GD40b), 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
MDR CriteriaProfessional usePublished evidence

Validation Publications

Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.

15197:2013 - Pass General population

15197:2003 - Pass General population