EU DECLARATION OF CONFORMITY
Fresenius Medical Care AG & Co. KGaA
Else-Kröner-Str. 1
61352 Bad Homburg – Germany
SRN: DE-MF-000008193
declares under his sole responsibility that the product
Product Name: Clip for stay•safe® Organizer
GMN / Basic UDI-DI: 4039361-0000-0000-0029-NU
Product group: PD handling devices
Intended Purpose: Facilitating of handling of other medical devices in a
peritoneal dialysis treatment
meets the applicable provisions as stated below and the relevant standards and
common specifications as specified in the technical documentation.
Applicable regulation/s: European Medical Device Regulation 2017/745
Risk class: Class I according to Rule 1
(according to Annex VIII Medical Device
Regulation 2017/745)
Conformity assessment Art. 52(7) & Annex IV (Declaration of Conformity)
procedure: according Regulation (EU) 2017/745 (MDR)
Notified body: Not applicable
Notified body no.: Not applicable
EU certificate: Not applicable
Place, Date: Bad Homburg, 27-Aug-2021
. .
i.V.________________________________ ppa________________________________
Dr. Rüdiger Amberg Dr. Thomas Himstedt
Product Center Responsible Person Responsible person acc. MDR Art. 15
This Declaration of Conformity is valid until withdrawn or reissued due to significant product change, new product code or new/changed regulatory/legal requirement.
Property of Fresenius Medical Care Page 1 of 2
EU DECLARATION OF CONFORMITY
Versions:
Product code Product name
F00006845 Clip for stay•safe® Organizer
Accessories:
(according to the European Medical Device Regulation 2017/745)
Product code Product name
- -
Additional equipment:
(Additional equipment which can be used with the respective product, is not covered by this Declaration of Conformity)
Product code Product name
- -
This Declaration of Conformity is valid until withdrawn or reissued due to significant product change, new product code or new/changed regulatory/legal requirement.
Property of Fresenius Medical Care Page 2 of 2
