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 ROC.
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 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 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 or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | Not recommended | This device has not been 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
Legend: Z Almost Certain
Legend: Z Almost Certain