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Riester ri-champion smartPRO+ (TD-3128B)

Device Name:ri-champion smartPRO+
Device Model:TD-3128B
Manufacturer:

OBL: Rudolf Riester GmbH, Bruckstraße 31, D-72417 Jungingen, GERMANY.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN PRC.

Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Riester ri-champion smartPRO+ (TD-3128B) is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for professional use.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Riester ri-champion smartPRO+ (TD-3128B) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.

Device Family:Riester ri-champion smartPRO (TD-3128A)Z, Riester ri-champion smartPRO+ (TD-3128B)Z, Smart Care TD-3128Z, TaiDoc TD-3128AZ, TaiDoc TD-3128BZ (Z Almost Certain)