Yuwell 906
Device Model:
906
Manufacturer:
Jiangsu Yuyue Medical Equipment and Supply Co. Ltd. (Yuwell), Yunyang Industrial Park, Danyang, Jiangsu 212300, CHINA.
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
Description:
The Yuwell 906 is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Yuwell 906, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
Device Family:
Validation Publications:
Lu Y. Clinical performance study of Blood Glucose Monitoring System Clinical Performance Study Report. 2024 Sep 25. 13 p. Report No. YK-IVD202405/V1.0. Details from: GCP Archives of the Second Affiliated Hospital of Nanjing Medical University and Jiangsu Yuyue Kailite Biotechnology Co. Ltd..
15197:2013 (aka 15197:2015) - Pass General population
Yuwell Y900 test strips - glucose dehydrogenase method.