Singapore HSA registration DE0000549
Gambro Prismaflex™ Haemodialysis Control Unit
Singapore·CLASS C·Gambro Lundia AB·Registered May 03, 2005Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0000549
- Registration Date
- May 03, 2005
- Change Notification Approval Date
- October 16, 2024
- Retention Due Date
- August 09, 2025
Product description
The Prismaflex control unit is intended for: - Continuous Renal Replacement Therapy for patients with acute renal failure and/or fluid overload. - Therapeutic Plasma Exchange Therapy for patients with diseases where removal of plasma components is indicated. - Hemoperfusion for patients with conditions where immediate removal of substances by adsorption is indicated. - Hemopurification for patients with conditions where extracorporeal elimination of carbon dioxide is indicated (only applicable for SW version 8.10 and above). All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Product Owner
- Name
- Gambro Lundia AB
- Short Name
- Gambro Lundia AB
- Address
- Box 10101, Magistratsvägen 16, SE-220 10 Lund, SWEDEN
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)
- Prismaflex Prismaflex Prismaflex Warmer holder Hardware 8.XX upgrade kit BIOS CD HP Cartridge Holder
- Model Identifier(s)
- 113082 114489 955052 G5002301 G5052302 G5052502 K35164001
About this record
Access comprehensive regulatory information for Gambro Prismaflex™ Haemodialysis Control Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0000549 and owned by Gambro Lundia AB. The device was registered on May 03, 2005.
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