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Baxter Softpac Citrate - HSA Registration DE0505609

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.

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CLASS C
DE0505609
Baxter Softpac Citrate
HSA Registration Number: DE0505609
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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.

Device 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 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