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SD Biosensor STANDARD Mentor (01GM21)

SD Biosensor STANDARD Mentor (01GM21)
Device Name:STANDARD Mentor, GlucoMentor
Device Model:01GM21
Manufacturer:Sole: SD Biosensor, C 4&5 Floor - Digital Empire Building 16, Deogyeong Dareo 1556beon gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC of KOREA.
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:

While the technology used in the SD Biosensor STANDARD Mentor (01GM21), 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.
Institute of Health Economics (CA)General useNo evidence provided