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EC Declaration of Conformity

Date: 2025-08-05

Product Information

Manufacturer:	Beurer GmbH (see address in footer)
SRN:	DE-MF-000005422
Product category:	Hearing amplifier
Product type:	HA 20
Intended use:	The hearing amplifier is used to help people hear better
Article number:	641.06, 641.97, 100.15, 100.45

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

Conformity Specifications

(EU) 2017/745	Medical device regulation (MDR)
Basic-UDI-DI:	4211125HA20LZ
Classification/applied rule(s):	Class IIa/rule 9
Conformity assessment procedure:	Annex IX, Chapter I
Notified Body Certificate:	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: D1311700063, valid to 2026-04-07
2011/65/EU	Restrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
Standard:	EN IEC 63000:2018

Declaration Statement

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 Meternek, Director Quality Management & Regulatory Affairs

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