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Atoma 11115

Device Model:11115
Manufacturer:

Distributer: McKesson Canada Retail Banner Services (Atoma), 131 McNabb Street, Markham, Ontario L3R 5V7, CANADA.

OBL: McKesson Canada Corporation (Atoma), 4705 Dobrin St., Saint-Laurent, Quebec H4R2P7, CANADA.

OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, 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:Available Currently
Assessment:

While the technology used in the Atoma 11115, 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
MedavalNot recommendedThis device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
Hypertension CanadaSelf-measurement (Gold)Manufacturer declaration of equivalence