

Accuracy Assessment | Recommendation | Basis | |
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 |
Legend: P Stride Equivalence, X Equivalence claim in publication
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
Medaval 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.
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)