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iHealth CardioMed (ABP100)

iHealth CardioMed (ABP100)
Device Name:CardioMed
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:Not available yet
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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaABPMPublished 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