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TaiDoc TD-4258C VTrust POCT
Device Name:
VTrust POCT
Device Model:
TD-4258C
Manufacturer:
TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for professional use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Specifications:
Description:
The TaiDoc TD-4258C VTrust POCT 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 taken from the finger. It is intended for professional use.
Assessment:
While the technology used in the TaiDoc TD-4258C VTrust POCT, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified. It also appears to be very similar to another device by the same (OEM) manufacturer, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BG TÜV Rheinland Nederland General use Unpublished internal data
Device Family:
Fora MD Control, POCT S10 (TD-4258)Z, TaiDoc TD-4258 VTrust POCTZ, TaiDoc TD-4258C VTrust POCTZ
Legend: Z Almost Certain