Yuwell 650
Device Model:
650
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
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Description:
The Yuwell 650 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 Yuwell 650, to measure blood glucose, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Yuwell 660
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.