HSA · registration DE0508773Fresenius CDS3 Concentrate Delivery System
- Registration number
- DE0508773
- Model name
- CDS3 Control Unit; CDS3 Hydraulic Unit; Power Supply CDS3; Connect Cable CDS3 - 3 m; Connect Cable CDS3 - 5 m; Connect Cable CDS3 - 10 m
- Model identifier
- F00006695; F00006696; F00006697; F00006700; F00006701; F00006703
- Registration date
- December 19, 2023
- Risk class
- Class B
- Product owner
- Fresenius Medical Care AG
- Registrant / registration holder
- FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
The CDS3 may only be used for the delivery of concentrates to haemodialysis devices. The CDS3 (concentrate delivery system) is a device for the delivery of acid concentrates from storage tanks. The fluids are transported from storage tanks via a ring main system. Dialysis devices use the acid concentrates to prepare the dialysates. Two storage tanks per concentrate can be connected. These are monitored by internal or external sensors for detecting an empty tank and are controlled by the CDS3. The CDS3 is operated in the immediate vicinity of the concentrate containers outside the treatment room.
- Product owner address
- Else-Kroner-Str. 1, 61352 Bad Homburg, Germany
- Registrant address
- 250 NORTH BRIDGE ROAD, #05-01, RAFFLES CITY TOWER, Singapore 179101
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.