HYPHEN BIOPHEN DiXal - HSA Registration DE0510047
Access comprehensive regulatory information for HYPHEN BIOPHEN DiXal in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510047 and owned by HYPHEN BioMed. The device was registered on November 15, 2024.
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.
Anti-Xa chromogenic method for the in vitro quantitative determination of direct Factor Xa inhibitors (DiXaIs), in human citrated plasma, using an automated method. This method is for aid to diagnosis to detect anticoagulant status (Apixaban, Rivaroxaban and Edoxaban) in patients on oral anticoagulants therapy. This device of in vitro diagnostic use is intended for professional use in the laboratory.