Singapore HSA registration DE0505609
Baxter Softpac Citrate
Singapore·CLASS C·Baxter Healthcare SA·Registered March 31, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505609
- Registration Date
- March 31, 2021
- Change Notification Approval Date
- May 08, 2024
- Retention Due Date
- March 30, 2026
Product description
The SoftPac Citrate product is intended to be used as a citrate-based acid concentrate together with a dry sodium bicarbonate cartridge for online preparation of hemodialysis fluids on compatible Baxter/Gambro dialysis systems.
Product Owner
- Short Name
- Baxter Healthcare SA
- Address
- Thurgauerstrasse 130, 8152 Glattpark (Opfikon), SWITZERLAND
Registrant
- Address
- 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
- Address
- 150 BEACH ROAD, GATEWAY WEST, #30-01/08, SINGAPORE 189720 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model information
- Model Name(s)
- Softpac Citrate C2040 Softpac Citrate C2065 Softpac Citrate C365 Softpac Citrate C265 Softpac Citrate C240
- Model Identifier(s)
- 955965 955966 955967 955968 955969
About this record
Access comprehensive regulatory information for Baxter Softpac Citrate in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505609 and owned by Baxter Healthcare SA. The device was registered on March 31, 2021.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C