HSA · registration DE0509709Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
- Registration number
- DE0509709
- Model name
- Gentuity HF-OCT Imaging System; Vis-Rx Micro-Imaging Catheter
- Model identifier
- G10-01; G30-03
- Registration date
- August 30, 2024
- Risk class
- Class D
- Product owner
- Gentuity, LLC
- Registrant / registration holder
- NIPRO ASIA PTE LTD
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
- Product owner address
- 142 North Road, Suite G, Sudbury, Massachusetts 01776, United States
- Registrant address
- 6 TEMASEK BOULEVARD, #31-01/02, SUNTEC TOWER FOUR, Singapore 038986
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.