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Rossmax MW821f

Device Model:MW821f
Manufacturer:Sole: Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, TAIWAN PRC.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Device Accessibility:Voiced instructions and results
Availability:Discontinued but still available
Assessment:

While the technology used in the Rossmax MW821f, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementA validation, without a reference, which Medaval is unable to identify.

Validation Publications for Equivalent Devices

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.

Rossmax ME701

de Greeff A, Shennan AH. The Rossmax (ME 701 series) upper arm device: accuracy assessment in an adult population according to the International and the British Hypertension Society protocols. Blood Press Monit. 2008 Feb;13(1):43-8. doi: 10.1097/MBP.0b013e3282ca913f. PMID: 18199923.

BHS:1993 - Pass (A/A) General population

SP10:1996 - Pass General population