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Riester ri-medic Desk

Device Name:ri-medic Desk
Device Model:1780-003, 1781-003
Manufacturer:

OBL: Rudolf Riester GmbH, Bruckstra├če 31, D-72417 Jungingen, GERMANY.

OEM: SunTech Medical Inc., Suite 117, 507 Airport Boulevard, Morrisville, NC 27560-8200, UNITED STATES.

Measuring functions:Blood pressure
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the Riester ri-medic Desk, 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
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Hospital useManufacturer declaration of equivalence
ESH (Europe)Professional useThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Riester ri-medic DeskB, Riester ri-medic FloorB, Riester ri-medic WallB, Suntech 247B (B BIHS Derivative)
Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Suntech 247

Polo Friz H, Facchetti R, Primitz L, Beltrame L, Galbiati V, Ricioppo A, Bombelli M, Sega R. Simultaneous validation of the SunTech 247 diagnostic station blood pressure measurement device according to the British Hypertension Society protocol, the International Protocol and the Association for the Advancement of Medical Instrumentation standards. Blood Press Monit. 2009 Oct;14(5):222-7. doi: 10.1097/MBP.0b013e328330c873. PMID: 19741510.

ESH-IP:2002 - Pass General population

BHS:1993 - Pass (A/A) General population

SP10:2002 - Pass General population