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Smart Care TD-3128

Device Model:TD-3128
Manufacturer:

OBL: Saify Traders (Smart Care), Akabar Villa, 14/1 RNT Marg, Street No. 1, Behind Dawa Bazar, Indore 452001, Madhya Pradesh, INDIA.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, 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
Description: The Smart Care TD-3128 is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Smart Care TD-3128 to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.