Biosensors BioFreedom Ultra Drug Coated Coronary Stent System - HSA Registration DE0506039
Access comprehensive regulatory information for Biosensors BioFreedom Ultra Drug Coated Coronary Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0506039 and owned by Biosensors Europe SA. The device was registered on August 02, 2021.
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 BioFreedom Ultra DCS is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging from 2.25 mm to 4.0 mm. Stents with lengths of 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm.