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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 57

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

SpecificationDetails
(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI4211125IH57P2
Classification/applied rule(s)Class IIa/rule 12 and rule 20
Conformity assessment procedureAnnex IX, Chapter I
Notified Bodymdc medical device certification GmbH, located at Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483
Certificate no. and validityD1311700063, valid to 2026-04-07
2011/65/EURestrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
StandardEN IEC 63000:2018

Signatory Information

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 and stamp of Werner Meternek]

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IH 57 EC DoC Beurer 20250806 BE Adobe PDF Library 15.0

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