Manuals+

EC Declaration of Conformity

Date: 2025-08-06

Manufacturer and Product Details

Manufacturer:Beurer GmbH (see address in footer)
SRN:DE-MF-000005422
Product category:Nebulizer
Product type:IH 60
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.

SpecificationDetails
(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI:42111251H60NP
Classification/applied rule(s):Class IIa/rule 12 and rule 20
Conformity assessment procedure:Annex IX, Chapter I

Notified Body and 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/EURestrictions 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
ppa. [signature]
Beurer GmbH
Söflinger Straße 218 • 89077 Ulm

PDF preview unavailable. Download the PDF instead.

IH 60 EC DoC Beurer 20250806 BE Adobe PDF Library 15.0

Related Documents

Preview Beurer IH 25/2 Nebulizer EC Declaration of Conformity - IH 26
Official EC Declaration of Conformity for the Beurer IH 25/2 Nebulizer (Model IH 26), confirming compliance with EU Medical Device Regulation (MDR) 2017/745 and RoHS 2011/65/EU.
Preview 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.
Preview Beurer BR 60 Insect Bite Healer EC Declaration of Conformity
Official EC Declaration of Conformity for the Beurer BR 60 insect bite healer (Model BR 90), detailing compliance with EU regulations and standards.
Preview 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.
Preview Beurer IH 57 Nebulizer EC Declaration of Conformity
Official EC Declaration of Conformity for the Beurer IH 57 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS directives.
Preview 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.
Preview 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.
Preview Beurer BM 36 EC Declaration of Conformity - Blood Pressure Monitor
Official EC Declaration of Conformity for the Beurer BM 36 blood pressure monitor, confirming compliance with EU Medical Device Regulation (MDR) and RoHS standards.