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Little Doctor LD12 (V2)

Device Model:LD12
Manufacturer:Little Doctor International (S) Pte. Ltd., 35 Selegie Road, 09-05 Parkline Shopping Centre, 188307 Singapore, SINGAPORE.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Little Doctor LD12 (V2) is a clinically validated automatic blood pressure monitor. Measurements are taken from the wrist and it is intended for self-measurement and home use.
Assessment:

While the technology used in the Little Doctor LD12 (V2), 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

Device Family:Honsun Scian LD-735B, Little Doctor LD12 (V2)B (B BIHS Derivative)
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.

Honsun Scian LD-735

Kang YY, Chen Q, Li Y, Wang JG Validation of the SCIAN LD-735 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2016 Aug;21(4):255-8. Epub: 2016 April 18. doi: 10.1097/MBP.0000000000000192. PMID: 27093702.

ESH-IP:2010 - Pass General population