Manufacturer Information
| Manufacturer: | Beurer GmbH (see address in footer) |
| SRN: | DE-MF-000005422 |
| Product category: | Nebulizer |
| Product type: | IH 15 |
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.
| (EU) 2017/745 | Medical device regulation (MDR) |
| Basic-UDI-DI: | 4211125IH15NJ |
| Classification/applied rule(s): | Class IIa/rule 12 and rule 20 |
| Conformity assessment procedure: | Annex IX, Chapter I |
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: | D1311700058, valid to 2026-04-07 |
| 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, 2025-07-16 |
| Name, function, signature, stamp: |
Werner Meternek, Director Quality Management & Regulatory Affairs ppa. [Signature of Werner Meternek] Beurer GmbH Söflinger Straße 218 • 89077 Ulm |
