Singapore HSA registration DE0508773
Fresenius CDS3 Concentrate Delivery System
Singapore·CLASS B·Fresenius Medical Care AG·Registered December 19, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508773
- Registration Date
- December 19, 2023
- Retention Due Date
- December 18, 2025
Product description
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
- Short Name
- Fresenius Medical Care AG
- Address
- Else-Kroner-Str. 1, 61352 Bad Homburg, GERMANY
Registrant
- Address
- 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
- Address
- 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model information
- Model Name(s)
- 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(s)
- F00006695 F00006696 F00006697 F00006700 F00006701 F00006703
About this record
Access comprehensive regulatory information for Fresenius CDS3 Concentrate Delivery System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508773 and owned by Fresenius Medical Care AG. The device was registered on December 19, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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