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TaiDoc GlucoRx Q (TD-4235B)

Device Name:GlucoRx Q
Device Model:TD-4235B
Manufacturer:

Distributer: GlucoRx Ltd., 4 Wintonlea, Monument Way West, Woking, Surrey GU21 5EN, UNITED KINGDOM.

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 and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the TaiDoc GlucoRx Q (TD-4235B), 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

Thakur P. Accuracy Evaluation of a Blood Glucose Meter System for Self-Testing with Three Strip Lots Following ISO 15197:2013 and EN ISO 15197:2015 Rep Dis Mark. 2017 Nov 13;1(1):101 (2 p). Available from: www.omicsonline.org. Letter.

15197:2013 - Pass General population