SD Biosensor STANDARD GlucoNavii PRO BT (01GM61-1)
Device Name:
STANDARD GlucoNavii PRO BT
Device Model:
01GM61-1
Manufacturer:
SD Biosensor, C 4&5 Floor - Digital Empire Building 16, Deogyeong Dareo 1556beon gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC of KOREA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for professional use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Description:
The SD Biosensor STANDARD GlucoNavii PRO BT (01GM61-1) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for professional use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the SD Biosensor STANDARD GlucoNavii PRO BT (01GM61-1) to measure blood glucose.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | Not recommended | This device has not been clinically validated. |