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EC Declaration of Conformity

Date: 2025-08-05

Product Details

Manufacturer:
Beurer GmbH (see address in footer)
SRN:
DE-MF-000005422
Product category:
Blood pressure monitor
Product type:
BM 36

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 Information

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

(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI:4211125BM36N2
Classification/applied rule(s):Class IIa/rule 10
Conformity assessment procedure:Annex IX, Chapter I

The notified body mdc medical device certification GmbH, located at Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483, issued in the course of the mentioned conformity assessment procedure the following certificate:

Certificate no. and validity:D1311700063, valid to 2026-04-07
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 Metemek, Director Quality Management & Regulatory Affairs
ppa. [signature]
Beurer GmbH
Söflinger Straße 218 • 89077 Ulm

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BM 36 EC DoC Beurer 20250805 BE Adobe PDF Library 15.0

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