Gambro Prismaflex™ HF Disposable Set - HSA Registration DE0000548
Access comprehensive regulatory information for Gambro Prismaflex™ HF Disposable Set in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0000548 and owned by Gambro Industries. 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.
The Prismaflex set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered)in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. This set is intended for use in the following veno-venous therapies: SCUF; CVVH;CVVHD; CVVHDF.