EU Declaration of Conformity

In accordance with Art. 52 No. 7 of the EU Regulation EU 2017/745 of the Council on Medical Devices (of 05.04.2017) declares

SEGUFIX®-Bandagen, Das Humane System GmbH & Co. KG (SRN: DE-MF-000027702), hereby declares under sole responsibility that the basic safety and performance requirements according to Annex I of this regulation are met for the following medical device:

Item 1206, Item 1204, Item 1205, Item 1216, Item 1214, Item 1215	SEGUFIX®-Magnetic Lock black / segufix.com
Item 1208, Item 1218	SEGUFIX®-Magnetic Key red

according to the 2025 price list.

Basis-UDI-DI = PP01531120629 / Risk class = I

Intended use:

- Item 1206: closing of SEGUFIX® systems
- Item 1208: quick release of the SEGUFIX®-Magnetic Lock black / segufix.com

The conformity assessment procedure according to Annexes II and III of the EU Regulation EU 2017/745 has been applied. This declaration is valid from the date of issue until May 24th, 2028.

Jesteburg, May 25th, 2026

Date of issue

R. W. de Sánchez

- Managing Director -