Singapore HSA registration DE0503675
Baxter PrisMax
Singapore·CLASS C·Baxter Healthcare SA·Registered October 01, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503675
- Registration Date
- October 01, 2019
- Change Notification Approval Date
- March 13, 2025
- Retention Due Date
- September 30, 2025
Product description
The PrisMax control unit is intended for : • Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. • Therapeutic Plasma Exchange (TPE) therapy for patients with diseases where removal of plasma components is indicated. • Hemoperfusion (HP) for patients with conditions where immediate removal of substances by adsorption is indicated. • Extracorporeal CO2 Removal (ECCO2R) for patients with conditions where extracorporeal elimination of carbon dioxide is indicated (only applicable for PrisMax Control Unit software 3.0 or later).
Product Owner
- Short Name
- Baxter Healthcare SA
- Address
- 8010 Zurich, 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)
- TherMax TherMax Blood Warmer Disposable PrisMax PrisMax Prismalung+ HP-X/PrismaLung+ PrisMax Software Upgrade Kit
- Model Identifier(s)
- 955515 955516 955558 955725 955742 955743 SC8010
About this record
Access comprehensive regulatory information for Baxter PrisMax in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503675 and owned by Baxter Healthcare SA. The device was registered on October 01, 2019.
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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