BTL Cardiopoint BTL-08 ABPM (V1)
While the technology used in the BTL Cardiopoint BTL-08 ABPM (V1), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|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||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|
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.
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