mdc medical device certification GmbH

certifies that

Beurer GmbH
Söflinger Straße 218
89077 Ulm
Germany
with the locations listed in the attachment
for the scope
design, development, manufacturing, sales, distribution and customer service of
blood pressure monitors, thermometers, ECG, pulse oximeters, infrared lamps,
daylight therapy lamps, nebulizers, TENS/EMS devices, hearing aids, breast pumps,
blood glucose monitoring systems, lancing devices, massage devices,
TENS/EMS electrodes, body fat scales, heart rate monitors, IPL devices,
dental care products, bite healer, CPR devices, medical masks, lice combs and
corresponding accessories and software applications;
sales and distribution of medical devices
has introduced and applies a

Quality Management System

The mdc audit has proven that this quality management system
meets all requirements of the following standard

EN ISO 13485
Medical devices – Quality management systems –
Requirements for regulatory purposes
EN ISO 13485:2016 + AC:2018 + A11:2021 - ISO 13485:2016

Valid from 2023-11-30

Valid until 2026-11-29
Registration no. D1311700056
Report no. P23-00626-267171
Stuttgart 2023-11-22

Head of Certification Body

mdc medical device certification GmbH

Kriegerstraße 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
Internet: http://www.mdc-ce.de For electronic publication only
 Attachment of the certificate

No. D1311700056 date 2023-11-22 Page 1 of 1

Location Scope
Beurer GmbH design, development, manufacturing, sales and distribution of blood
Söflinger Straße 218 pressure monitors, thermometers, ECG, pulse oximeters, infrared lamps,
89077 Ulm daylight therapy lamps, nebulizers, TENS/EMS devices, hearing aids,
breast pumps, blood glucose monitoring systems, lancing devices,
massage devices, TENS/EMS electrodes, body fat scales, heart rate
monitors, IPL devices, dental care products, bite healer, CPR devices,
medical masks, lice combs and corresponding accessories and software
applications;
sales and distribution of medical devices
Beurer GmbH manufacturing and distribution of blood pressure monitors,
Riedlingerstraße 41 thermometers, ECG, pulse oximeters, infrared lamps, daylight therapy
88524 Uttenweiler lamps, nebulizers, TENS/EMS devices, hearing aids, breast pumps,
blood glucose monitoring systems, lancing devices, massage devices,
TENS/EMS electrodes, body fat scales, heart rate monitors, IPL devices,
dental care products, bite healer, CPR devices, medical masks, lice
combs and corresponding accessories
Beurer GmbH customer service of blood pressure monitors, thermometers, ECG, pulse
Lessingstraße 10b oximeters, infrared lamps, daylight therapy lamps, nebulizers,
89231 Neu-Ulm TENS/EMS devices, hearing aids, breast pumps, blood glucose
monitoring systems, lancing devices, massage devices, TENS/EMS
electrodes, body fat scales, heart rate monitors, IPL devices, dental care
products, bite healer, CPR devices, medical masks, lice combs and
corresponding accessories and software applications

Head of Certification Body

mdc medical device certification GmbH

Kriegerstraße 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
Internet: http://www.mdc-ce.de For electronic publication only