Device Model:
Q06
Manufacturer:
Hingmed Medical Instrument Co. Ltd., 4F Zhonghang Flying Industrial Park, 371 Guangshen Road, Xixiang, Bao’an District, Shenzhen, 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:
Available Currently
Device Manual:
Description:
The Hingmed Q06 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 Hingmed Q06 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.
Hingmed Q06B
Li R, Han W, Yang J, He H, Yang L, Wang S, Palatini P. Reliability of oscillometric blood pressure measurement using a wide-range cuff from 22 to 41 cm of arm circumference: validation of the Hingmed Q06B upper arm blood pressure monitor for blood pressure measurement at home evaluated in a general population according to the International Organization for Standardization 81060-2:2018 protocol. Blood Press Monit. Epub: 2025 Jul 3. doi: 10.1097/MBP.0000000000000762. PMID: 40762520.
81060-2:2018/Amd 1:2020/Amd 2:2024 - Pass General population
