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EC Declaration of Conformity

Date: 2025-08-06

Manufacturer & Product Identification

Manufacturer:Beurer GmbH (see address in footer)
SRN:DE-MF-000005422
Product category:Nebulizer
Product type:IH 24 (Model: IH 24 Kids)

Intended Use

Nebulizers (including compressor, ultrasonic, and mesh nebulizers) are medical devices for the nebulization of liquids and liquid medication (aerosols). This device produces aerosols by combining compressed air and liquid medication. The aerosol treatment is suitable for treating the upper and lower airways. By nebulizing and inhaling the medication prescribed / recommended by your doctor, you can prevent diseases affecting the airways, or in the case that you contract such an illness, you can alleviate symptoms and speed up your recovery.

Conformity Specifications

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

RegulationDetails
(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI:4211125IH24NK
Classification/applied rule(s):Class IIa/rule 12 and rule 20
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:

Certificate Number & 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)
RoHS Standard:EN IEC 63000:2018

Declaration and Authorization

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. Beurer GmbH
Söflinger Straße 218 • 89077 Ulm

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IH 24 Kids EC DoC Beurer 20250806 BE Adobe PDF Library 15.0

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