All Medicus GlucoDr SuperSensor (AGM-2200)
Device Name:
GlucoDr SuperSensor
Device Model:
AGM-2200
Manufacturer:
All Medicus Co. Ltd., Room 7608, 140 Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do 431-804 (Room 7106, Dong-il Techno Town 7-cha, 823 Gwanyang 2 dong, Dongan-gu, Anyang-si, Gyeonggi-do 431-716), REPUBLIC of KOREA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Description:
The All Medicus GlucoDr SuperSensor (AGM-2200) 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 All Medicus GlucoDr SuperSensor (AGM-2200), 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |