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iHealth CardioMed (ABP100)
Device Model:
ABP100
Manufacturer:

OBL: iHealthlabs Europe SAS, 36 Rue de Ponthieu, 75008 Paris, FRANCE.

OEM: Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.

Measuring functions:
Blood pressure
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 and South Africa
Description:
The iHealth CardioMed (ABP100) is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm and it is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the iHealth CardioMed (ABP100), to measure blood pressure, 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
Medaval ★★ Recommendation Recent clinical validation; recent protocol
Stride BP ABPM for adults (Preferred) Published evidence
MDR Criteria ABPM Published evidence
Validation Publications:

Kollias A, Ntineri A, Kyriakoulis KG, Stambolliu E, Stergiou GS. Validation of the iHealth ambulatory blood pressure monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization standard. Blood Press Monit. 2018 Apr;23(2):115-6. Epub: 2018 Feb 05. doi: 10.1097/MBP.0000000000000314. PMID: 29406327.

81060-2:2013 - Pass General population