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Combei BP885W
Device Model:
BP885W
Manufacturer:
Combei Technology Co. Ltd., Floor 3, Bldg. B, Jinxiongda Technology Park, 105 Huanguan South Road, Dahe Community, Guanlan Street, Bao'an, Shenzhen, Guangdong 518110, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Combei BP885W 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 wrist. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Combei BP885W, 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:
Combei BP885WY, Medisana BW 320 (51074)Y
Legend: Y Internal declaration