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Atoma 11116

Device Model:11116
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: Shenzhen Urion Technology Co. Ltd., 4th Building, High-Tech Industrial Zone, Heping District, Fuyong St., Bao'an, Shenzhen, Guangdong 518103, CHINA.

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 11116, 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 CanadaGeneral useManufacturer declaration of equivalence