Manuals+

EU Quality Management System Certificate

Certificate Holder Information

Company: Beurer GmbH

Address: Söflinger Straße 218, 89077 Ulm, Germany

Compliance and Certification Details

This certificate confirms that Beurer GmbH has implemented and applies a quality management system in accordance with Annex IX, Chapter I and III of Regulation (EU) 2017/745 for conformity assessment.

An audit by mdc has proven that this quality management system meets the requirements of Annex IX – Chapter I (Quality Management System) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

Surveillance is carried out in accordance with Annex IX, Section 3 of Regulation (EU) 2017/745.

This certificate from mdc medical device certification GmbH (Notified Body 0483) consists of 3 pages. Details about the devices covered as well as further information and conditions are contained on the following pages.

Valid from: 2025-07-28

Valid until: 2026-04-07

Date of Issue: Stuttgart, 2025-07-28

Registration Number: D1311700063

Report Number: P24-01247-311356

SRN: DE-MF-000005422

Notified Body: mdc medical device certification GmbH

Previous Certificates Referenced:

Changes to D1311700058: Supplemented by Software modules for diagnostic purposes.

Covered Devices

The quality management system covers the following devices:

mdc medical device certification GmbH | Kriegerstraße 6 | 70191 Stuttgart | Germany | www.mdc-ce.de

PDF preview unavailable. Download the PDF instead.

D1311700063 Beurer EU 2017-745 Microsoft Word LTSC Microsoft Word LTSC

Related Documents

Preview Beurer BR 60 Insect Bite Healer EC Declaration of Conformity
Official EC Declaration of Conformity for the Beurer BR 60 insect bite healer (Model BR 90), detailing compliance with EU regulations and standards.
Preview Beurer Module.MAP EC Declaration of Conformity
Declaration of Conformity for Beurer Module.MAP medical device software, confirming compliance with EU regulations.
Preview Beurer BM 53 EC Declaration of Conformity
Official EC Declaration of Conformity for the Beurer BM 53 blood pressure monitor, confirming compliance with EU Medical Device Regulation (MDR) and RoHS standards.
Preview Beurer BM 27 Blood Pressure Monitor EC Declaration of Conformity
This document presents the EC Declaration of Conformity for the Beurer BM 27 blood pressure monitor (Model BM 30), confirming its compliance with EU regulations, including the Medical Device Regulation (MDR) and restrictions on hazardous substances (RoHS).
Preview Beurer Medical Devices Regulation (MDR EU 2017/745) Guide for Distributors
An overview of the EU Medical Devices Regulation (MDR) 2017/745, detailing obligations for distributors and manufacturers, Unique Device Identifiers (UDI), and device classification, provided by Beurer.
Preview Beurer BM 36 EC Declaration of Conformity - Blood Pressure Monitor
Official EC Declaration of Conformity for the Beurer BM 36 blood pressure monitor, confirming compliance with EU Medical Device Regulation (MDR) and RoHS standards.
Preview Beurer IH 24 Nebulizer: EC Declaration of Conformity
Official EC Declaration of Conformity for the Beurer IH 24 Nebulizer (Model: IH 24 Kids), confirming compliance with EU Medical Device Regulation (MDR) 2017/745 and RoHS standards.
Preview Beurer IH 60 Nebulizer EC Declaration of Conformity
Official EC Declaration of Conformity for the Beurer IH 60 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS directives. Details manufacturer information, product specifications, and regulatory compliance.