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SD Biosensor STANDARD GlucoNavii GDH (01GM30)

Device Name:STANDARD GlucoNavii GDH
Device Model:01GM30
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
Description: The SD Biosensor STANDARD GlucoNavii GDH (01GM30) is a non-clinically-validated blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the SD Biosensor STANDARD GlucoNavii GDH (01GM30) to measure blood glucose.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not been clinically validated.