Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter - HSA Registration DE0509709
Access comprehensive regulatory information for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509709 and owned by Gentuity, LLC. The device was registered on August 30, 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.
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure