Yuwell 660
Device Model:
660
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 660 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 660, 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 test strips (glucose dehydrogenase method) Clinical Performance Study Report. 2023 Jul 11. 60 p. Report No. YK-IVD202204/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 Y350 test strips - glucose dehydrogenase method.