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Beurer BM 35

Device Model:BM 35
Manufacturer:

OBL: Beurer GmbH, Söflinger Straße 218, 89077 Ulm, GERMANY.

OEM: Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN PRC.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Assessment:

The Beurer BM 35 is included in a current validation and equivalence audit, by Medaval, in preparation for (EU) 2017/745. Validation details will be posted when this has been completed.

Accuracy AssessmentRecommendationBasis
Medaval
DHL (DE)General useManufacturer declaration of equivalence
ESH (Europe)Self-measurementPublished evidence

Device Family:Beurer BM 35D, Braun BP-4900D, Braun BP-5900D, H&L HL868BAB,D, Proton PHCP-868BFB, Seagull S-868BAB (B BIHS Derivative, D DET 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.

H&L HL868BA

Chen HE, Cui Y, Sheng CS, Li LH, Li Y, Wang JG. Validation of the Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2008 Oct;13(5):305-8. doi: 10.1097/MBP.0b013e32830d4bd0. PMID: 18799958.

ESH-IP:2002 - Pass General population