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Omron RS2 (HEM-6121-E)

Omron RS2 (HEM-6121-E)
Device Name:RS2
Device Model:HEM-6121-E
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
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
Click here to download the Device Manual
Assessment:

While the technology used in the Omron RS2 (HEM-6121-E), to measure blood pressure, has been declared 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.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
DHL (DE)General useManufacturer declaration of equivalence
 
Consumer BodyVersionQuartileComment
Stiftung Warentest (DE)Most recent: 2018B 
Which? (UK)2019A 

Device Family:Omron RS1 (HEM-6120-D)D, Omron RS3 (HEM-6130-E)B,D (B BIHS DerivativeD DET Equivalence)