Meditech ABPM-05
The technology used in the Meditech ABPM-05, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Accuracy Assessment | Recommendation | Basis | ||
---|---|---|---|---|
Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
BIHS (UK and IRL) | ABPM | Manufacturer declaration of equivalence | ||
ESH (Europe) | ABPM | Published evidence |
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.
Meditech ABPM-04
Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.
BHS:1993 - Pass (B/B) General population
SP10:1992 - Pass General population