Beurer BM 53 Medel Elite Plus EC Declaration of Conformity

Product Information

Manufacturer:	Beurer GmbH (see address in footer)
SRN:	DE-MF-000005422
Product category:	Blood pressure monitor
Product type:	BM 53 (Model: Medel Elite Plus)

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/Standard	Details
(EU) 2017/745	Medical device regulation (MDR)
Basic-UDI-DI:	4211125BM53N2
Classification/applied rule(s):	Class IIa/rule 10
Conformity assessment procedure:	Annex IX, Chapter I
Notified Body Certificate:	Issued by mdc medical device certification GmbH, located at Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483. Certificate no. and validity: D1311700063, valid to 2026-04-07.
2011/65/EU	Restrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
EN IEC 63000:2018

Declaration and Signatory

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

Beurer GmbH
Söflinger Straße 218 • 89077 Ulm

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Product Information

Intended Use

Conformity Specifications

Declaration and Signatory

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