Andon BM-091

Andon BM-091
Device Model:BM-091
Manufacturer:Sole: Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.
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
Click here to download the Device Specifications
Assessment: The technology used in the Andon BM-091, to measure blood pressure, has been compared to a validated device but the results of the 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.
Device Family:Andon KD-5031D, Andon KD-556D, Andon KD-557B, Andon KD-558B, Andon KD-5901B, Andon KD-5902B, Andon KD-5905B, Andon KD-5909B, Andon KD-5915B,D, Andon KD-5917B, Andon KD-5918B, Andon KD-595B, Andon KD-5961B, Andon KD-5962B, Andon KD-5913D, Andon KD-5001B, Andon KD-5963D, Andon KD-5971B,D, Beurer BM-44D, Beurer BM-47D, Beurer BM-58D, Beurer BM-65D, Beurer SBM-43D, Desa Pharma Tecnico EasyB, iHealth Track (KN-550BT)B, Medel Check (V1)D, Medel EliteD, Pic Solution Digit SmartD, Pic Solution Digit ExtraD, Salter BPA-9200-GBB, Salter BPA-8200-EUB (B BIHS Derivative, D DET Equivalence)
Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

Andon KD-5031

Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Oct;21(5):310-2. Epub: 2016 Jul 7. doi: 10.1097/MBP.0000000000000204. PMID: 27392206.

ESH-IP:2010 - Pass General population

Andon KD-5915

Huang QF, Wang J, Sheng CS, Zhang NN, Li Y, Wang JG. Validation of the ANDON KD-5915 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2010 Aug;15(4):232-4. PMID: 20658765.

ESH-IP:2002 - Pass General population

Andon KD-5917

Guo WG, Li BL, He Y, Xue YS, Wang HY, Zheng QS, Xiang DC. Validation of the Andon KD-5917 automatic upper arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Aug;19(4):242-5. doi: 10.1097/MBP.0000000000000048. PMID: 24847724.

ESH-IP:2010 - Pass General population

Andon KD-595

Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD-595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Apr;21(2):124-7. Epub: 2015 Nov. doi: 10.1097/MBP.0000000000000164. PMID: 26544523.

ESH-IP:2010 - Pass General population

Beurer BM-44

Lüders S, Krüger R, Zemmrich C, Forstner K, Sturm CD, Bramlage P. Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002. Blood Press Monit. 2012 Dec;17(6):248-52. doi: 10.1097/MBP.0b013e32835b9e8e. PMID: 23147534.

ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)