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Fora Diamond Prima (DM10)

Device Name:Fora Diamond Prima
Device Model:DM10
Manufacturer:Puyang Technology Co. Ltd. (ForaCare), 1st Floor, 127 Wugong 2nd Road, Wugu District 24888, 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
Description: The Fora Diamond Prima (DM10) is a clinically validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for self-measurement and home use.
Assessment:

While the technology used in the Fora Diamond Prima (DM10), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhile a clinical validation is claimed, it cannot be checked properly.
TÜV SÜD (DE)General useUnpublished internal data