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 5204/r, Item 5304/r, Item 5404/r, Item 5104/r, Item 5101/r

SEGUFIX®-Hand Waist Restraint

in the sizes offered according to the 2025 price list.

Basis-UDI-DI = PP01531520456 / Risk class = I

Intended use:

- to restrain hands of patients during transfer (requires continous monitoring)
- prevents patients from injuring themselves or others, e. g. accompanying personnel during transfer
- physically restraining patients

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 -