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Beurer BM 59 Blood Pressure Monitor - EC Declaration of Conformity

EC Declaration of Conformity

Date: 2025-08-05

Product Information

Manufacturer:Beurer GmbH (see address in footer)
SRN:DE-MF-000005422
Product category:Blood pressure monitor
Product type:BM 59

Intended Use

The blood pressure monitor is intended for the fully automatic, non-invasive measurement of arterial blood pressure and pulse values on the upper arm. It is designed for self-measurement by adults in a domestic environment.

Conformity Specifications

The product specified above is in conformity with the following specifications.

Regulation/DirectiveDetails
(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI:4211125BM59NE
Classification/applied rule(s):Class IIa/rule 10
Conformity assessment procedure:Annex IX, Chapter I
Certificate no. and validity:D1311700063, valid to 2026-04-07
2014/53/EURadio equipment directive (RED)
EN 62479:2010
EN 50663:2017
EN IEC 62368-1:2020 + A11:2020
EN 301 489-1 V2.2.3 (2019-11)
EN 301 489-17 V3.2.4 (2020-09)
EN 300 328 V2.2.2 (2019-07)
2011/65/EURestrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
EN IEC 63000:2018

Declaration and Signature

This declaration of conformity is issued under the sole responsibility of the manufacturer.

Signed for and on behalf of:Beurer GmbH
Place, date of issue:Ulm, 2025-08-05
Name, function, signature, stamp:Werner Meternek, Director Quality Management & Regulatory Affairs

ppa. [Signature of Werner Meternek]

Beurer GmbH
Söflinger Straße 218 • 89077 Ulm

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BM 59 EC DoC Beurer 20250805 BE Adobe PDF Library 15.0

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