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Custo Med custo screen 400

Device Name:custo screen 400
Manufacturer:custo med GmbH, Maria-Merian-Straße 6, D-85521 Ottobrunn, GERMANY.
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:

The accuracy of the technology used in the Custo Med custo screen 400, to measure blood pressure, is certified by Medaval Ltd.

Accuracy AssessmentRecommendationBasis
Medaval★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence
ESH (Europe)ABPMPublished evidence
Stride BPABPM (Preferred)Published evidence

Validation Publications

Bramlage P, Deutsch C, Krüger R, Wolf A, Müller P, Zwingers T, Beime B, Mengden T. Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2014 May 13;10:303-9. doi: 10.2147/VHRM.S63602. PMID: 24868162. Available from: PMC4027883.

ESH-IP:2010 - Pass General population

Medaval Certification Assessment

Cert ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the custo med custo screen 400 upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1616) 4 p. Epub: 2019 Jan 31. Available from: https://www.medaval.ie/MDA/2016/MDA1616.pdf.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Custo Med custo screen 400, is certified by Medaval Ltd.