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Ypsomed MyLife Unio

Device Name:MyLife Unio
Manufacturer:

OBL: Ypsomed Distribution AG, Brunnmattstrasse 6, CH-3401 Burgdorf, SWITZERLAND.

OEM: Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, TAIWAN PRC.

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

The technology used in the Ypsomed MyLife Unio, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
TÜV Rheinland NederlandGeneral useUnpublished internal data
MDR CriteriaSelf-measurement and professional usePublished evidence

Validation Publications

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.

15197:2003 - Pass General population

15197:2013 - Pass General population

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

FDA:2016H - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2013/100

SKUP. Report from the evaluation SKUP/2013/100: MyLife Unio (Ypsomed, Bionime Corporation), a system for blood glucose measurement. Bergen, Norway: SKUP; 2013. 55 p. Available from: skup.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements)

Results counted in Sølvik et al. 2015.