Yuwell YE991 - Medaval

Description:

The Yuwell YE991 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 use as a public facility.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Yuwell YE991 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:

Yuwell YE990P, Yuwell YE991Z, Yuwell YE992P
Legend: P Stride Equivalence, 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.

Yuwell YE990

Xu D, Tang H, Wang C, Cheng H, Wu W, Lu Q, Liu H. Validation of the YuWell YE990 medical automatic electronic blood pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018/Amd.1:2020). Blood Press Monit. 2025 Aug 1;30(4):191-195. Epub: 2025 May 6. doi: 10.1097/MBP.0000000000000755. PMID: 40327332.

81060-2:2018/Amd 1:2020 - Pass General population

Du X, Wang X, Li X, Li T, Lv W, Yin Z. Validation of the YuWell YE990 automatic oscillometric blood pressure monitor in mid-to-late pregnancy according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Common Criteria (AAMI/ESH/ISO 81060-2:2018/Amd.1:2020). Blood Press Monit. 2026 Apr 1;31(2):95-100. Epub: 2025 Dec 9. doi: 10.1097/MBP.0000000000000787. PMID: 41410342.

81060-2:2018/Amd 1:2020 - Pass Pregnancy