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 1406, Item 1404, Item 1405 | SEGUFIX®-Push Lock / Push Button / Push Socket |
| Item 1408, Item 1417, Item 1418 | SEGUFIX®-Push Key |
according to the 2025 price list.
Basis-UDI-DI = PP01531120629 /
Risk class = I
Intended use:
- Art. 1406: For locking of SEGUFIX®-Systems (without magnetic mechanism, can be used in close proximity to pacemakers)
- Art. 1408: For opening of the push 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 -