Skymed SureTest TD-4227
Device Name:
SureTest
Device Model:
TD-4227
Manufacturer:
OBL: Skymed Monitors Inc., 10613 172 Street Northwest, Edmonton, Alberta T5S 1P1, CANADA.
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 self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Device Accessibility:
Voiced instructions and results
Availability:
Available Currently
Description:
The Skymed SureTest TD-4227 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 self-measurement and home use.
Assessment:
While the technology used in the Skymed SureTest TD-4227, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |