Bionime Rightest GM550
Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, TAIWAN ROC.
Primary Client Use:
Intended for both professional use and self-measurement
Finger and general Alternative Site Testing
Single measurements only
Availability according to Countries or Regions:
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. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
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.
|BG||Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|BG||TÜV Rheinland Nederland||General use||Unpublished internal data|
|BG||Institute of Health Economics (CA)||General use||No evidence provided|
|BG||MDR Criteria||Self-measurement and professional use||Published evidence|
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