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EC Declaration of Conformity

Date: 2025-08-06

Manufacturer and Product Identification

Manufacturer:Beurer GmbH (see address in footer)
SRN:DE-MF-000005422
Product category:Infrared lamp
Product type:IL 35
Intended use:The infrared lamp is intended for irradiating the human body. By irradiating with infrared light, heat is transported to the human body.
Article number:616.12, 616.87, 607.85

Conformity to Specifications

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

Specification / RegulationDetails / Compliance
(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI:4211125IL35PC
Classification/applied rule(s):Class IIa/rule 9
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: D1311700063, valid to 2026-04-07
2011/65/EURestrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
EN IEC 63000:2018

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

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IL 35 EC DoC Beurer 20250806 BE Adobe PDF Library 15.0

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