DiabaScan Pro (TD-4235)
Device Name:
Pro
Device Model:
TD-4235
Manufacturer:
OBL: Vertech Health Solutions India (P) Ltd. (DiabaScan), 304-305 V4 Mayur Plaza - V, Block - G, Kondli, Gharoli, Mayur Vihar Phase - 3, Delhi 110096, INDIA.
OEM: 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
Description:
The DiabaScan Pro (TD-4235) 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 DiabaScan Pro (TD-4235), 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 Assessment | Recommendation | Basis | |
| 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |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: