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Menarini GlucoMen Nexus (TD-4277)

Device Name:GlucoMen Nexus
Device Model:TD-4277
Manufacturer:

OBL: A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN PRC.

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 GlucoMen Nexus (TD-4277), 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

Salzsieder E, Berg S. Accuracy Evaluation of a CE-Marked System for Self-Monitoring of Blood Glucose With Three Reagent System Lots Following ISO 15197:2013. J Diabetes Sci Technol. 2016 Jan;10(1):238-9. Epub: 2015 Sep 22. doi: 10.1177/1932296815606471. PMID: 26394775. Available from: PMC4738220. No abstract available.

15197:2013 - Pass General population

TaiDoc GlucoRx Nexus (TD-4277), Menarini GlucoMen Nexus (TD-4277) and Aktivmed GlucoCheck XL (TD-4277) are described as being the same device.