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VivaChek Ino

Device Name:Ino
Manufacturer:

Distributer: VivaChek Laboratories Inc., Suite 200, 913 N Market Street, Wilmington, DE 19801, UNITED STATES.

Sole: VivaChek Biotech (Hangzhou) Co. Ltd., Level 2, Block 2, 146 East Chaofeng Road, 311100 Hangzhou, CHINA.

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
Assessment:

The technology used in the VivaChek Ino, 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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Hehmke B, Berg S, Salzsieder E. Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013. J Diabetes Sci Technol. 2017 May;11(3):635-6. Epub: 2016 Oct 4. doi: 10.1177/1932296816670401. PMID: 27707915. Available from: PMC5505413.

15197:2013 - Pass General population