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 ROC.

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 an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Seagull S-868ED, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Stride BP Self-measurement for adults (Preferred) Equivalence claim without published evidence
Device Family:
H&L HL858GT TalkingP, H&L HL868EDP, H&L HL858A2-TP, Seagull S-868EDP
Legend: 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

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