Yuwell 582

Device Model:

582

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

Device Accessibility:

Voiced instructions and results

Connected Health Technologies:

Bluetooth

Availability:

Available Currently

Description:

The Yuwell 582 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 582, 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:

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

Validation Publications:

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.