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Menarini Glucocard SM

Device Name:Glucocard SM
Manufacturer:A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Menarini Glucocard SM, 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 CriteriaSelf-measurementPublished evidence

Validation Publications

Bright D, Dunseath G, Berti F, Scuffi C, Valgimigli F, Luzio S. Accuracy Evaluation of a Blood Glucose Monitoring System According to EN ISO 15197:2015. J Diabetes Sci Technol. 2017 Jul;11(4):849-50. Epub: 2017 Feb 1. doi: 10.1177/1932296817695340. PMID: 28745087. Available from: PMC5505433.

15197:2013 - Pass General population