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Xuerui XR-BP-1307
Device Model:
XR-BP-1307
Manufacturer:
Shanghai Xuerui Import & Export Co. Ltd., Room 06 - 10/F Block B, SilvaBay Tower, 269 Haining Road, 200080 Shanghai, CHINA.
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 Xuerui XR-BP-1307 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:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Xuerui XR-BP-1307 to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer, but equivalence needs to be proven according to a protocol compliant 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.
Device Family:
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 HL868BA

Chen HE, Cui Y, Sheng CS, Li LH, Li Y, Wang JG. Validation of the Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2008 Oct;13(5):305-8. doi: 10.1097/MBP.0b013e32830d4bd0. PMID: 18799958.

ESH-IP:2002 - Pass General population

Sejoy Joytech DBP-1307 (Sejoy BP-1307, Joytech DBP-1307)

Lei L, Chen Y, Chen Q, Li Y, Wang JG. Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2017 Dec;22(6):371-4. Epub: 2017 Aug 03. doi: 10.1097/MBP.0000000000000283. PMID: 28786853 .

ESH-IP:2010 - Pass General population