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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 and PR
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
Availability according to Countries or Regions:
Ireland
Device Manual:
Click here to download the Device Manual
Description:
The Custo Med custo screen 400 is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 4-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
The accuracy of the technology used in the Custo Med custo screen 400, to measure blood pressure, is certified by Medaval Ltd. It has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★★ Certified Accuracy Older clinical validation; recent protocol with certified adherence
BP ESH (Europe) ABPM Published evidence
BP Stride BP ABPM for adults (Previously Preferred) Published evidence
Device Family:
Custo Med custo screen 300P,X, Custo Med custo screen 400X, Custo Med custo screen PediatricP, Custo Med custo screen 310P
Legend: P Stride Equivalence, X Equivalence claim in publication
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

Certification 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) 5 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

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.

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.

Custo Med custo screen Pediatric

Beime B, Deutsch C, Krüger R, Wolf A, Müller P, Hammel G, Bramlage P. Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Eur J Pediatr. 2017 May;176(5):573-80. Epub: 2017 Feb 24. doi: 10.1007/s00431-017-2874-3. PMID: 28236027.

ESH-IP:2010 - Pass Children, aged 3 to 12 years (n=33)

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