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SD Biosensor Codefree (01GM11)

Device Name:Codefree
Device Model:01GM11
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 Codefree (01GM11) is a clinically validated blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

The technology used in the SD Biosensor Codefree (01GM11), to measure blood glucose, has been assessed, in a general population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications

Choukem SP, Sih C, Nebongo D, Tientcheu P, Kengne AP. Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study. Pan Afr Med J. 2019 Mar 14;32:118. doi: 1011604/pamj20193211815553. PMID: 31223408. Available from: PMC6561013.

Ad Hoc protocol General population