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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