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Omron HEA-230
Device Model:
HEA-230
Manufacturer:

OBL: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

OEM: DELBio Inc., 3F - 252 Shangying Road, Guishan Industrial Zone, Taoyuan County 33341, 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
Description:
The Omron HEA-230 is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood glucose measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:
The technology used in the Omron HEA-230, 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; older protocol
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 - Fail General population

15197:2003 - Pass General population