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HT One Lumina (OK-14V)

Device Name:Lumina
Device Model:OK-14V
Manufacturer:

OBL: GD Medical Pharma BV (HT One), Hastelweg 224, 5652 CL Eindhoven, NETHERLANDS.

OEM: OK Biotech Co. Ltd., 91 Sec. 2, Gongdao 5th Road, Hsinchu City 30070, 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:

While the technology used in the HT One Lumina (OK-14V), 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 is not published and cannot be checked.
TÜV Rheinland NederlandGeneral useUnpublished internal data