Urion U80C
Device Model:
U80C
Manufacturer:
Shenzhen Urion Technology Co. Ltd., 4th Building, High-Tech Industrial Zone, Heping District, Fuyong St., Bao'an, Shenzhen, Guangdong 518103, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Urion U80C is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Urion U80C, to measure blood pressure, 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 AssessmentRecommendationBasis
BP Medaval Not recommended This device has not been shown to have been clinically validated.
Device Family:
Medisana BU 512 (51162)Y, Medisana BU 514 (51165)Y, Urion U80CY
Legend: Y Internal declaration