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EC Declaration of Conformity

Date: 2025-08-06

Manufacturer Information

Manufacturer:	Beurer GmbH (see address in footer)
SRN:	DE-MF-000005422

Product Details

Product category:	Pulse oximeter
Product type:	PO 13 (Model: PO 13 Kids)
Intended use:	The pulse oximeter is used for non-invasive measurement of arterial oxygen saturation (SpO2) and heart rate (pulse rate) at home and in hospitals (not in AP and APG-class rooms). This device is not suitable for long-term measurement.

Conformity Specifications

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

Regulation:	(EU) 2017/745 - Medical device regulation (MDR)
Basic-UDI-DI:	4211125PO13R2
Classification/applied rule(s):	Class IIa/rule 10
Conformity assessment procedure:	Annex IX, Chapter I
Notified Body:	mdc medical device certification GmbH, Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483
Certificate no. and validity:	D1311700063, valid to 2026-04-07
RoHS Compliance:	2011/65/EU - Restrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
Standard:	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, 2025-08-06
Name, function, signature, stamp:	Werner Meternek, Director Quality Management & Regulatory Affairs ppa. [signature]

Beurer GmbH • Soeflinger Str. 218 • 89077 Ulm • Germany

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