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EC Declaration of Conformity

Date: 2025-08-05

Manufacturer Information

Manufacturer:Beurer GmbH (see address in footer)
SRN:DE-MF-000005422

Product Details

Product category:Bite healer
Product type:BR 60 (Model: BR 59)
Intended use:The insect bite healer is intended for relieving itching and swelling caused by insect bites or stings by applying heat (local hyperthermia).

Product Specifications and Conformity

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

(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI:4211125BR60NQ
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: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

Declaration and Signature

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, 2025-08-05
Name, function, signature, stamp:Werner Meternek, Director Quality Management & Regulatory Affairs
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BR 59 EC DoC Beurer 20250805 BE Adobe PDF Library 15.0

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