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Bionime Rightest GM550
Device Model:
GM550
Manufacturer:
Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, TAIWAN ROC.
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
Availability according to Countries or Regions:
United States
Device Specifications:
Description:
The Bionime Rightest GM550 is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:
The technology used in the Bionime Rightest GM550, 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 AssessmentRecommendationBasis
Medaval ★★ Recommendation Recent clinical validation; recent protocol
TÜV Rheinland Nederland General use Unpublished internal data
Institute of Health Economics (CA) General use No evidence provided
MDR Criteria Self-measurement and professional use Published evidence
Validation Publications:

Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.

15197:2013 - Pass General population

15197:2003 - Pass General population