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Cardioline Walk200b

Device Name:Cardioline Walk200b
Manufacturer:

Distributer: Elettromedical SAS di Boscato Giorgio, Km. 2.400, Strada Provinciale 120 Sestu, Elmas 400, 09028 Sestu (CA), ITALY.

Other: Cardioline SPA, Via Fratelli Bronzetti, 8, 20129 Milano, ITALY.

Measuring functions:Blood pressure, ECG
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

While the technology used in the Cardioline Walk200b, 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)ABPMManufacturer declaration of equivalence
ESH (Europe)ABPMThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Cardioline Walk200bB, IEM Mobil-O-Graph NGB, Medset Scanlight-IIIB, Welch Allyn ABPM 7100B (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.

IEM Mobil-O-Graph NG

Franssen PM, Imholz BP. Evaluation of the Mobil-O-Graph new generation ABPM device using the ESH criteria. Blood Press Monit. 2010 Aug;15(4):229-31. PMID: 20658764.

ESH-IP:2002 - Pass General population

Weiß W, Tölle M, Zidek W, van der Giet M. Validation of the mobil-O-Graph: 24 h-blood pressure measurement device. Blood Press Monit. 2010 Aug;15(4):225-8. doi: 10.1097/MBP.0b013e328338892f. PMID: 20216407.

BHS:1993 - Pass General population