Home /  Riester E-Mega (2-tube)

Riester E-Mega (2-tube)

Device Name:E-Mega (2-tube)
Device Model:White: 1371-151 , Black: 1376-151
Manufacturer:Rudolf Riester GmbH, Bruckstra├če 31, D-72417 Jungingen, GERMANY.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the Riester E-Mega (2-tube), to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.

Accuracy AssessmentRecommendationBasis
MedavalNoneThis is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements.
BIHS (UK and IRL)Professional useManufacturer declaration of equivalence to a device without published evidence
ESH (Europe)Professional useThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.