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 7260, Item 7360, Item 7460, Item 7160, Item 7266, Item 7366, Item 7466, Item 7166

SEGUFIX®-Chair Belt with Thigh Straps

in the sizes and versions offered according to the 2025 price list.

Basis-UDI-DI = PP01531726092 / Risk class = I

Intended use:

- to support and position patients in wheelchairs and other compatible chairs
- prevents the patient from sliding off of the seat
- physically restraining patients
- Item 7260, Item 7360, Item 7460 : attaches behind the backrest w ith a snap lock
- Item 7266, Item 7366, Item 7466 : attaches behind the backrest w ith a lock

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 -