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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 CanadaSelf-measurement (Silver)Manufacturer declaration of equivalence