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Rossmax Accumed Carrdio C5

Device Name:Accumed Carrdio C5
Manufacturer:

Brand: Rossmax Swiss GmbH (Accumed), Tramstrasse 16, CH-9442 Berneck, SWITZERLAND.

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
Availability:Discontinued but still available
Description: The Rossmax Accumed Carrdio C5 is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

While the technology used in the Rossmax Accumed Carrdio C5, 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.

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-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Alvita CG-155FB, Alvita MA-801FB, Aspen C5B, Aspen CF155FB, Lloyds CardioZ, Rossmax AC1000f (V1)B, Rossmax Accumed Carrdio C5B, Rossmax CF155fB, Rossmax CF175f (V1)B,P, Rossmax CH155f (V1)B, Rossmax CH155f (V2)B, Rossmax X1 (V1)B,P, Rossmax X3 (V1)B,P, Rossmax X5 (V1)B, Rossmax X9B, Rossmax X9 BTZ, Rossmax Z1B, Rossmax Z5B (B BIHS Derivative, P Stride Equivalence, Z Almost Certain)
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 CF175f (V1)

Zhang L, Kang YY, Zeng WF, Li Y, Wang JG. Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Apr;20(2):104-7. doi: 10.1097/MBP.0000000000000089. PMID: 25350783.

ESH-IP:2010 - Pass General population