Device Name:
08E (Note: 2 of 2)
Manufacturer:
Contec Medical Systems Co. Ltd., 112 Qinhuang West Street, Economic &Technical Development Zone, Qinhuangdao 066004, Hebei Provice, 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
Description:
The Contec 08E (V2) 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 Contec 08E (V2), 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 Assessment | Recommendation | Basis |
| 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 to the Contec 08A claim without published evidence |
Device Family:
Contec 08AP,
Contec 08E (V2)PLegend:
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.
Contec 08A
Zhou Y, Zhou Y, Zou RY, Li Y, Wang JG. Validation of the CONTEC08A upper-arm blood pressure monitor in adult Chinese. Blood Press Monit. 2025 Jun 1;30(3):109-112. Epub: 2025 Jan 31. doi: 10.1097/MBP.0000000000000743. PMID: 40013499.
81060-2:2018/Amd 1:2020 - Pass General population
Chen M, Wang W, Wang L, Bian J, Ma W, Bai J, Lou Y, Cai J. Validation of the CONTEC08C oscillometric blood pressure monitor in adults according to the International Organization for Standardization 81060-2:2018 standard. Blood Press Monit. Epub: 2025 Nov 3. doi: 10.1097/MBP.0000000000000781. PMID: 41186208.
81060-2:2018 - Pass General population
