Electronic Instructions for Use and Distributor Information
Hereby we fulfill Chapter III Article 23.1. of MDR. Besides the paper-based IFU which is supplied with the Medical Device, you will have the opportunity to get a digital version. It may occur that some devices do not have an IFU at all, because Class I and Class IIa devices are not required to have an IFU acc. to Chapter III Article 23.1 part d) of MDR.
We recommend the eIFUs to be downloaded, printed, reviewed, and readily available for reference. Patients should keep their product information guides always available. When using Fresenius Kabi AG devices, licensed Medical Healthcare Professionals should keep product IFUs readily available for the operator’s reference during any procedure.
Specifications in IFUs, manuals and other documentation may change for different versions of a product. Consequently, using the incorrect version of an IFU, manual or other documentation may lead to erroneous results. Please be sure that you obtain the correct document and version for the Fresenius Kabi AG product you are using. Your use of this site constitutes your acknowledgment that you are responsible for obtaining and using the correct version of the document that corresponds to the version of the product you are using and that Fresenius Kabi AG will bear no responsibility or liability for your failure to do so. If you have any question about which version of an IFU or other document to use, please contact your local Fresenius Kabi AG representative.
If you have difficulties accessing documents or would like to request a printed copy at no extra cost, please contact Fresenius Kabi AG, with the website Revision Number “for example eIFU-00 2021-02” as reference:
Fresenius Kabi MedTech
61352 Bad Homburg, Germany
Phone.: +49 (0) 6172 / 686-0
Additionally to the electronic Instructions for Use (eIFU) of our Medical Devices, we will provide you on this website:
- Summary of Safety and Clinical Performance (SSCP) as long as EUDAMED is not available for public.
- ISO 13485/9001
- Declaration of Conformity (DoC)
- Certificates of Quality (CoQ)