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 2724, Item 2824

SEGUFIX®-Hand Restraint extended Velcro

according to the 2025 price list.

Basis-UDI-DI = PP01531574542 / Risk class = I

Intended use:

- positioning of one or both hands in bed
- also compatible with ambulance stretchers
- not a restraint (note: some jurisdictions consider Velcro products as a restraint, should the patient not be able to remove them without help) For use without SEGUFIX®-Standard with Crotch Strap or SEGUFIX®-Standard with Thigh Straps

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 -