Contec 08D - Medaval

Description:

The Contec 08D 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 08D, 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	Equivalence to the Contec 08A claim without published evidence

Device Family:

Contec 08AP, Contec 08C (V2)P, Contec 08E (V2)P, Contec 08ES1P, Contec 08ES3P, Contec 08ES4P, Contec 08ES5P, Contec 801P, Contec 802P, Contec 08CLP, Contec 08DP
Legend: 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

Contec 08C (V2)

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. 2026 Apr 1;31(2):86-89. Epub: 2025 Nov 3. doi: 10.1097/MBP.0000000000000781. PMID: 41186208.

81060-2:2018 - Pass General population