EC Declaration of Conformity

Manufacturer Information

Manufacturer: Beurer GmbH (see address in footer)

SRN: DE-MF-000005422

Product Details

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 Specifications

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

• (EU) 2017/745: Medical device regulation (MDR)
• Basic-UDI-DI: 4211125IL35PC
• Classification/applied rule(s): Class IIa/rule 9
• 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, 2025-06-16

Name, function, signature, stamp: Werner Meternek, Director Quality Management & Regulatory Affairs

ppa.

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