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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 ROC.

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 HT One Lumina (OK-14V) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG TÜV Rheinland Nederland General use Unpublished internal data