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SEGUFIX
CE

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 8015, Item 8025 SEGUFIX®-Response Bag
according to the 2025 price list.
Basis-UDI-DI = PP01531801535 / Risk class = I

Intended use:

  • - quick access for fast response
  • - protects SEGUFIX® products
  • - well arranged storage for your SEGUFIX®-sets, e.g. 1 SEGUFIX®-Complete (size L), 1 SEGUFIX®-Quick-Restraint-System (size M)
  • - space saver, several bags may be stacked for organized storage

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
Signature
R. W. de Sánchez
- Managing Director -