Grandway MD2640
Device Model:
MD2640
Manufacturer:
Grandway Healthcare Ltd., Room 1705, Kinox Centre, No. 9 Hung To Road, Kwun Tong, Kowloon, HONG KONG 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 Grandway MD2640 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 Grandway MD2640 to measure blood pressure. However, this device appears to be very similar to a validated device by the same 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:
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.
Grandway MD2680 (G.LAB)
Guo YF, Zhang XQ, Fu JL, Zhang X, Shan HZ, Shi N, Yan LQ. Validation of the G.LAB MD2680 digital automatic blood pressure monitor according to international protocols Blood Press Monit. 2017 Aug;22(4):221-5. Epub: 2017 Mar 10. doi: 10.1097/MBP.0000000000000254. PMID: 28288006.
ESH-IP:2010 - Pass General population
81060-2:2013 - Pass General population
BHS:1993 - Pass (A/A) General population