Yuwell 909
Device Model:
909
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 909 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 909, 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 906
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.