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EC Declaration of Conformity

Date: 2025-08-05

Manufacturer Details

Manufacturer: Beurer GmbH (see address in footer)

SRN: DE-MF-000005422

Product Category: Contact thermometer

Product Type: FT 16 (Model: FT 17)

Intended Use

The thermometer is intended exclusively for the orally, rectally or axillary measurement of human body. The thermometer is only intended for private use in a domestic environment and not for commercial use.

Conformity Specifications

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

Regulation/StandardDetails
(EU) 2017/745Medical device regulation (MDR)
Basic-UDI-DI44211125FT16PT
Classification/applied rule(s)Class IIa/rule 10
Conformity assessment procedureAnnex IX, Chapter I
Notified Bodymdc medical device certification GmbH, Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483
Certificate No. and ValidityD1311700063, valid to 2026-04-07
2011/65/EURestrictions of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
StandardEN 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

ppa. [Signature Placeholder] Beurer GmbH, Söflinger Straße 218 • 89077 Ulm

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FT 17 EC DoC Beurer 20250805 BE Adobe PDF Library 15.0

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