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 2212, Item 2312, Item 2412, Item 2112 | SEGUFIX®-Shoulder Additional Belt |
in the versions offered according to the 2025 price list.
Basis-UDI-DI = PP01531220327 /
Risk class = I
Intended use:
- - prevents the patient from sitting up in bed ( requires continous monitoring )
- - physically restraining patients Requirements : SEGUFIX®-Standard with Crotch Strap / Thigh Straps and SEGUFIX®-Shoulder Restraint Compatible with: SEGUFIX®-Shoulder Restraint ( not compatible with size XS ) SEGUFIX®-Quick Restraint Shoulder , SEGUFIX®-Compact
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 -