Product Information
Library for product-related documents compliant with the Medical Device Regulation (MDR):
Updates of product information (e.g., user information, Instructions for Use (IFU), Manuals and Declarations of Conformity (DoC) or Article 22 declarations) are made available to the user via this website. The documents can be searched in the database using the search function and the product name or the article number. Instructions for Use are provided in different languages depending on the relevant legislation and are indicated as two-letter language codes according to ISO 639.
The documents published on this website correspond to those approved according to the new Regulation (EU) 2017/745 (MDR) for medical devices. In case you are looking for older Instructions for Use, Manuals or Declarations of Conformity, please contact the local Fresenius Medical Care organization in your country.
If you require Xenios-related product information, please use the following link.
| Instructions for Use | Reference no. of finished product | Language | Edition date | Version/Software-Version | Declaration of Conformity |
|---|---|---|---|---|---|
| Clip for stay•safe® Organizer | F00006845 | en, de, fr, it, es, pt, el, nl, da, no, sv, fi, et, bg, hu, hr, sr, bs, ro, lv, lt, sk, sl, cs, pl, uk, ru, kk, tr, ar, fa, he, ja, ko, zhs, zht, th, is | 05/2020 | 1 | DoC |
| multiEffluent Bag 10 L Single-Use | 5029031 | en, de, bg, bs, cs, da, el, es, et, fi, fr, hr, hu, it, kk, ko, lt, lv, nl, no, pl, pt, ro, ru, sk, sl, sr, sv, zh | 01/2020 | 1 | DoC |
| multiEffluent Bag 10 L | 5029011 | en, de, bg, bs, cs, da, el, es, et, fi, fr, hr, hu, it, kk, ko, lt, lv, nl, no, pl, pt, ro, ru, sk, sl, sr, sv, zh | 01/2020 | 1 | DoC |
| Filtrate Bag 10 L | F00007116 | en, zh | 01/2021 | B | DoC |
| PatientOnLine | N/A | bg | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | cs | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | da | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | de | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | el | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | en | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | es | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | et | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | fi | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | fr | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | hr | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | hu | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | it | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | lt | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | nl | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | pl | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | pt | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | ro | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | sk | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | sl | 08A-2020 | 6.3 | DoC |
| PatientOnLine | N/A | sv | 08A-2020 | 6.3 | DoC |
| stay•safe® Holder for Organizer | 2842571N | en, de, fr, it, es, pt, el, nl, da, no, sv, fi, et, bg, hu, hr, sr, bs, ro, lv, lt, sk, sl, cs, pl, uk, ru, kk, tr, ar, fa, he, ja, ko, zhs, zht, th, is | 05/2020 | 1 | DoC |
| stay•safe® Organizer | 2842561N | en, de, fr, it, es, pt, el, nl, da, no, sv, fi, et, bg, hu, hr, sr, bs, ro, lv, lt, sk, sl, cs, pl, uk, ru, kk, tr, ar, fa, he, ja, ko, zhs, zht, th, is | 05/2020 | 1 | DoC |
| Therapy Monitor | N/A | cs | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | da | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | de | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | en | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | es | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | et | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | fi | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | fr | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | hr | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | hu | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | it | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | nl | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | pl | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | pt | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | ro | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | sk | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | sl | 12A-2019 | 2.3 | DoC |
| Therapy Monitor | N/A | sv | 12A-2019 | 2.3 | DoC |