EC Declaration of Conformity

Date: 2025-08-06

Product Information

Manufacturer:	Beurer GmbH (see address in footer)
SRN:	DE-MF-000005422
Product category:	Nebulizer
Product type:	IH 51 (Model: IH 49)

Intended Use

Nebulisers (including compressor, ultrasonic and mesh nebulisers) are medical devices for the nebulisation of liquids and liquid medication. This device produces aerosols by combining an oscillating mesh with holes and a liquid medication. The aerosol treatment is suitable for treating the upper and lower airways. By nebulising 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.
(EU) 2017/745	Medical device regulation (MDR)
Basic-UDI-DI:	4211125IH51NN
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 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)
	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, 2025-08-06
Name, function, signature, stamp:	Werner Meternek, Director Quality Management & Regulatory Affairs [signature] Beurer GmbH stamp with address

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