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Seagull S-868ED

Device Model:S-868ED
Manufacturer:

OBL: Seagull ApS, Valbyvej 71, 4200 Slagelse, DENMARK.

OEM: 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:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Seagull S-868ED is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

While the technology used in the Seagull S-868ED, to measure blood pressure, has been claimed 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.
Stride BPSelf-measurement for adults (Preferred)Equivalence claim without published evidence

Device Family:H&L HL868EDP, Seagull S-868EDP (P Stride 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 HL868ED

Zhang W, Lei L, Li Y, Wang JG. Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol. Blood Press Monit. 2019 Aug;24(4):203-207. Epub: 2019 May 23. doi: 10.1097/MBP.0000000000000384. PMID: 31136322. Erratum in: Blood Press Monit. 2021 Feb;26(1):85.

BHS:1993 - Pass (A/A) General population

Zhang W, Lei L, Li Y, Wang JG. Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2020 Feb;25(1):53-57. Epub: 2019 Oct. doi: 10.1097/MBP.0000000000000411. PMID: 31658108. Erratum in: Blood Press Monit. 2021 Feb;26(1):84.

ESH-IP:2010 - Pass General population