Gambro Prismaflex TPE1000 Set - HSA Registration DE0006406
Access comprehensive regulatory information for Gambro Prismaflex TPE1000 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 DE0006406 and owned by Gambro Industries. The device was registered on March 25, 2011.
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 TPE1000/TPE2000 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), after having selected TPE therapy (therapeutic plasma exchange). The PRISMAFLEX TPE1000/TPE2000 Set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

