According to COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 of 14 December 2021, laying down implementing rules for Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices, this page is intended exclusively for healthcare professionals.
By using this page, you confirm that you are a healthcare professional and accept the terms of use for this page.
Please select which instructions you would like to download:
Version 3.3
Effective since 2026-04
File format: PDF
According to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC, eIFUs must be made available in a conventional format.
Upon request, paper versions of the IFU will be provided free of charge within 7 calendar days of receiving your request within the EU. Please send us an email to safety@fibrothelium.com, including your name and full address.
To load, view, and print PDF files, you will need the appropriate software, such as Adobe Acrobat Reader. You can download the latest version of this program for free from the Adobe website.
Acrobat Reader can be launched from your web browser if it is properly configured. If the PDF plugin is installed in your browser, PDF files will be displayed directly in the browser, allowing you to continue using your browser’s navigation options. If the plugin is not installed, the PDF file will be saved to your hard drive and opened with Acrobat Reader.
Version 3.2
Effective since: 2025-07
Effective to: 2026-03
File format: PDF
Version 3.1
Effective since: 2024-09
Effective to: 2025-06
File format: PDF
Version 3.0
Effective since: 2022-11
Effective to: 2024-08
File format: PDF