EC Declaration of Conformity

Date: 2025-08-06

Manufacturer

Beurer GmbH (see address in footer)

Product Information

SRN:	DE-MF-000005422
Product category:	Nebulizer
Product type:	IH 25/2 (Model: IH 26)
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.

Specifications

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

(EU) 2017/745	Medical device regulation (MDR)
Basic-UDI-DI:	4211125IH25/23V
Classification/applied rule(s):	Class IIa/rule 12 and rule 20
Conformity assessment procedure:	Annex IX, Chapter I

Notified Body Information

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

	EC Declaration of Conformity - Beurer IH 25/2 Nebulizer Official EC Declaration of Conformity for the Beurer IH 25/2 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS standards.
	Beurer IH 51 Nebulizer EC Declaration of Conformity EC Declaration of Conformity for the Beurer IH 51 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS standards.
	Beurer IH 60 Nebulizer EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer IH 60 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS directives. Details manufacturer information, product specifications, and regulatory compliance.
	EC Declaration of Conformity - Beurer IH 51 Nebulizer EC Declaration of Conformity for the Beurer IH 51 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS directives. Includes product details, conformity specifications, and manufacturer information.
	EC Declaration of Conformity - Beurer IH 47 Nebulizer Official EC Declaration of Conformity for the Beurer IH 47 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS standards.
	Beurer IH 24 Nebulizer: EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer IH 24 Nebulizer (Model: IH 24 Kids), confirming compliance with EU Medical Device Regulation (MDR) 2017/745 and RoHS standards.
	Beurer IH 28 EC Declaration of Conformity EC Declaration of Conformity for the Beurer IH 28 Nebulizer, confirming compliance with Medical Device Regulation (EU) 2017/745 and RoHS directives.
	Beurer IH 15 Nebulizer EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer IH 15 Nebulizer, detailing its compliance with Medical Device Regulation (MDR) and RoHS standards.