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 ROC.
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
Device Manual:
Description:
The Menarini GlucoMen Nexus (TD-4277) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
| BG | MDR Criteria | Self-measurement | Published 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.