Yuwell 720 (V2)

Description:

The Yuwell 720 (V2) 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 720 (V2), 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:

Yuwell 580 AccusureY, Yuwell 582Y, Yuwell 710 (V2)Y, Yuwell 305Y, Yuwell 720 (V2)Y
Legend: Y Internal declaration

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 582

Lu Y. Clinical performance study of Blood glucose test strips (glucose oxidase method) Clinical Performance Study Report. 2023 Jul 17. 44 p. Report No. YK-IVD202302/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 Y330 test strips - glucose oxydase method.