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H&L HL168ZA

Device Model:HL168ZA
Manufacturer:Sole: Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN PRC.
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
Assessment:

While the technology used in the H&L HL168ZA, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

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

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.

H&L HL168JD

Sheng CS, Huang QF, Wang J, Zhang Y, Li Y, Wang JG. Validation of the Health & Life HL168JD wrist blood pressure monitor for home blood pressure monitoring according to the International Protocol. Blood Press Monit. 2009 Jun;14(3):125-7. doi: 10.1097/MBP.0b013e32832ce106. PMID: 19454865.

ESH-IP:2002 - Pass General population