EC Declaration of Conformity
Date: 2025-08-05
Manufacturer and Product Information
| Manufacturer: | Beurer GmbH (see address in footer) |
|---|---|
| SRN: | DE-MF-000005422 |
| Product category: | Bite healer |
| Product type: | BR 60 (Model: BR 10) |
| 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 |
| Certificate details: | 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/EU | Restrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS) |
| Standard: | EN IEC 63000:2018 |
Declaration and Signatory Information
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 |
(Signature placeholder)
Beurer GmbH • Söflinger Str. 218 • 89077 Ulm • Germany
Related Documents
 |
EC Declaration of Conformity - Beurer BR 60 Bite Healer Official EC Declaration of Conformity for the Beurer BR 60 (Model BR 59) insect bite healer, confirming compliance with relevant medical device regulations and RoHS standards. |
 |
Beurer BR 60 Insect Bite Healer EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer BR 60 insect bite healer (Model BR 90), detailing compliance with EU regulations and standards. |
 |
Beurer BR 60 EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer BR 60 insect bite healer, confirming compliance with EU Medical Device Regulation (MDR) and RoHS standards. |
 |
Beurer BM 25 EC Declaration of Conformity EC Declaration of Conformity for the Beurer BM 25 blood pressure monitor, confirming compliance with Medical Device Regulation (MDR) (EU) 2017/745, RoHS, and EN IEC 63000:2018 standards. |
 |
Beurer FT 16 EC Declaration of Conformity - Medical Device Compliance Official EC Declaration of Conformity for the Beurer FT 16 contact thermometer, confirming compliance with Medical Device Regulation (MDR) and RoHS standards. |
 |
Beurer IH 57 Nebulizer EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer IH 57 Nebulizer, confirming compliance with Medical Device Regulation (MDR) and RoHS directives. |
 |
Beurer BM 36 EC Declaration of Conformity - Blood Pressure Monitor Official EC Declaration of Conformity for the Beurer BM 36 blood pressure monitor, confirming compliance with EU Medical Device Regulation (MDR) and RoHS standards. |
 |
Beurer FT 16 EC Declaration of Conformity Official EC Declaration of Conformity for the Beurer FT 16 contact thermometer, confirming compliance with EU Medical Device Regulation (MDR) and RoHS standards. |