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Aktivmed GlucoCheck Neo

Device Name:GlucoCheck Neo
Manufacturer:

OBL: Aktivmed GmbH, Prinzregentenplatz 1, 86150 Augsburg, GERMANY.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN PRC.

Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Not made available
Assessment:

The technology used in the Aktivmed GlucoCheck Neo, 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

Jeanny G, Hope P. Surveillance of the System Accuracy of Two Systems for Self-Monitoring of Blood Glucose After Market Approval. J Diabetes Sci Technol. 2016 Jan;10(1):240-1. Epub: 2015 Sep 30. doi: 10.1177/1932296815608871. PMID: 26424240. Available from: PMC4738221. No abstract available.

15197:2013 - Pass General population

15197:2003 - Pass General population