Hemodialysis
Library for product-related documents compliant with the Medical Device Regulation (MDR)
Instructions for Use (IFU), manuals, and Declarations of Conformity (DoC) 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 Regulation (EU) 2017/745 for medical devices (MDR). 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.
| Product Information | Reference no. of finished product | Language | Edition date | Version/Software-Version | Declaration of Conformity |
|---|---|---|---|---|---|
| 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 |
| Anemia Control Model | N/A | en | 1/08.20 | 4.0 | DoC |
| Therapy Support Suite | N/A | en | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | it | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | da | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | de | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | nl | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | pl | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | sl | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | fi | 2/05.21 | 1.9 | DoC |
| Therapy Support Suite | N/A | sv | 2/05.21 | 1.9 | DoC |
| Anemia Control Model | N/A | es | 1/08.20 | 4.0 | DoC |
| AquaA | N/A | pl | 7A-2021 | 4.40 |
|
| AquaA | N/A | sv | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | sk | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | sl | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | pt | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | ro | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | en | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | cs | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | it | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | fr | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | es | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | fi | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | de | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | nl | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | da | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | hr | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | he | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | is | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | uk | 7A-2021 | 4.40 | DoC AquaA_all |
| AquaA | N/A | no | 7A-2021 | 4.40 | DoC AquaA_all |
| Therapy Support Suite | N/A | da | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | de | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | en | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | es | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | fi | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | fr | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | it | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | nl | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | pl | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | sl | 3-11.22 | 1.91 | DoC |
| Therapy Support Suite | N/A | sv | 3-11.22 | 1.91 | DoC |
| DWDL_DCDL | N/A | de | 02A-2023 | N/A | DoC |
| Therapy Monitor | N/A | en | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | cs | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | da | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | de | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | es | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | et | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | fi | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | fr | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | hr | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | hu | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | it | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | nl | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | pl | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | pt | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | ro | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | sk | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | sl | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | sv | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | bs | 12C-2022 | 2.3 | DoC |
| Therapy Monitor | N/A | en | 15A-2023 | 2.4 | DoC |
| Therapy Monitor | N/A | da | 15A-2023 | 2.4 | DoC |
| FME all Devices legal form | N/A | en, de, ar, bg, bs, cs, da, el, es, es-la, et, fa, fi, fr, fr-be, he, hr, hu, id, is, it, ja, ko, lt, lv, ms, nl, no, pl, pt, pt-br, ro, ru, sk, si, sr, sv, th, tr, uk, zhs, zht | 01A-2023 | N/A | N/A |
| FME all Software legal form | N/A | en, de, ar, bg, bs, cs, da, el, es, es-la, et, fa, fi, fr, fr-be, he, hr, hu, id, is, it, ja, ko, lt, lv, ms, nl, no, pl, pt, pt-br, ro, ru, sk, si, sr, sv, th, tr, uk, zhs, zht | 01A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | bg | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | bs | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | cs | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | da | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | el | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | en | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | es | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | et | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | fi | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | fr | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | hr | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | hu | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | it | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | lt | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | lv | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | nl | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | pl | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | pt | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | ro | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | sk | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | sl | 02A-2023 | N/A | N/A |
| DWDL_DCDL | N/A | sv | 02A-2023 | N/A | N/A |
| Anemia Control Model | N/A | en | 1-12.23 | N/A | N/A |
| Anemia Control Model | N/A | es | 1-12.23 | N/A | N/A |