Product Information
| Manufacturer: | Beurer GmbH (see address in footer) |
|---|---|
| SRN: | DE-MF-000005422 |
| Product category: | Blood pressure monitor |
| Product type: | BM 64 |
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
| Specification | Details |
|---|---|
| (EU) 2017/745 | Medical device regulation (MDR) |
| Basic-UDI-DI: | 4211125BM64N7 |
| 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 |
|---|
Applicable Directives and Standards
| Directive/Regulation | Standards |
|---|---|
| 2014/53/EU Radio equipment directive (RED) | EN 62479:2010 EN 50663:2017 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/EU Restrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS) | EN IEC 63000:2018 |
Declaration Statement
This declaration of conformity is issued under the sole responsibility of the manufacturer.
Authorized Signatory
| 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] Beurer GmbH Söflinger Straße 218 • 89077 Ulm |
Beurer GmbH • Soeflinger Str. 218 • 89077 Ulm • Germany
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