


Distributer: Nipro Medical Europe, Blokhuisstraat 42, 2800 Mechelen, BELGIUM.
Other: Nipro Corporation, 3-9-3 Honjo-Nishi, Kita-Ku, Osaka 531-8510, JAPAN.
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | MDR Criteria | Self-measurement | Published evidence |
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
Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.
15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot.)