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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 90)

Intended use: The insect bite healer is intended for relieving itching and swelling caused by insect bites or stings by applying heat (local hyperthermia).

Conformity Specifications

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

Specification Details
(EU) 2017/745 Medical device regulation (MDR)
Basic-UDI-DI 4211125BR60NQ
Classification/applied rule(s) Class IIa/rule 9
Conformity assessment procedure Annex IX, Chapter I
Notified Body mdc medical device certification GmbH, located at Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483.
Certificate no. and validity D1311700063, valid to 2026-04-07
2011/65/EU Restrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
Standard EN IEC 63000:2018

Declaration and Authorization

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 Metemek, Director Quality Management & Regulatory Affairs

(Signature placeholder)

Beurer GmbH
Söflinger Straße 218 · 89077 Ulm

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BR 90 EC DoC Beurer 20250805 BE Adobe PDF Library 15.0

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