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Nipro TRUEyou

Device Name:TRUEyou

Distributer: Nipro Medical Europe, Blokhuisstraat 42, 2800 Mechelen, BELGIUM.

Sole: Nipro Corporation, 3-9-3 Honjo-Nishi, Kita-Ku, Osaka 531-8510, JAPAN.

Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently

The technology used in the Nipro TRUEyou, 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

Jendrike N, Rittmeyer D, Pleus S, Baumstark A, Haug C, Freckmann G. ISO 15197:2013 Accuracy Evaluation of Two CE-Marked Systems for Self-Monitoring of Blood Glucose. J Diabetes Sci Technol. 2015 Jul;9(4):934-5. Epub: 2015 Apr 21. doi: 10.1177/1932296815582223. PMID: 25901021. Available from: PMC4525667. No abstract available.

15197:2013 - Pass General population