Device Model:
XR-BP-103H
Manufacturer:
OBL: Shanghai Xuerui Import & Export Co. Ltd., Room 06 - 10/F Block B, SilvaBay Tower, 269 Haining Road, 200080 Shanghai, CHINA.
OEM: Hangjhou Sejoy Electronics & Instrument Co. Ltd. Joytech Healthcare Co. Ltd., Area C Building 2, 365 Wuzhou Road, Yuhang Economic Development Zone, Yuhang District, Hangzhou City, Zhejiang 311100, CHINA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Xuerui XR-BP-103H 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Xuerui XR-BP-103H to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
Aspen BP-10 (BP-103H)Z,
Beurer BM 26P,
Beurer BM 40P,
Beurer BM 35/1D,P,
Braun BP-4900D,
Braun BP-5900D,
Healthcare World BP-103HZ,
Hartmann Veroval 2-in-1 ECG (BP750X)P,
HyMark DBP-1314 (BP-103H)Z,
LotFancy BP-103HZ,
LotFancy BP-1305Z,
Sejoy Joytech DBP-1204 (Sejoy BP-102)F,
Sejoy Joytech DBP-1314 (Sejoy BP-103H)F,
Sejoy Joytech DBP-1209 (Sejoy BP-1209)F,
Sejoy Joytech DBP-1303 (Sejoy BP-1303)F,
Sejoy Joytech DBP-1305 (Sejoy BP-1305, Joytech DBP-1305)F,
Sejoy Joytech DBP-1307 (Sejoy BP-1307, Joytech DBP-1307)B,P,F,
Sejoy Joytech DBP-1231F,
Sejoy Joytech DBP-1332F,
Sejoy Joytech DBP-1334F,
Spengler AutoTensio Arm (SPG440)P,
Spengler Tensonic ArmP,
Xuerui XR-BP-102Z,
Xuerui XR-BP-103HZ,
Xuerui XR-BP-1209Z,
Xuerui XR-BP-1303Z,
Xuerui XR-BP-1305Z,
Xuerui XR-BP-1307ZLegend:
B BIHS Derivative,
D DET Equivalence,
P Stride Equivalence,
F FDA 510(k),
Z Almost Certain
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.
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
