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Singapore HSA registration DE0509709

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

Singapore flagSingapore·CLASS D·Gentuity, LLC·Registered August 30, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509709
Registration Date
August 30, 2024
Retention Due Date
August 29, 2025
Product description
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
Name
Gentuity, LLC
Short Name
Gentuity, LLC
Address
142 North Road, Suite G, Sudbury, Massachusetts 01776, UNITED STATES
Registrant
Name
NIPRO ASIA PTE LTD
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
Name
NIPRO ASIA PTE LTD
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Model information
Model Name(s)
Gentuity HF-OCT Imaging System Vis-Rx Micro-Imaging Catheter
Model Identifier(s)
G10-01 G30-03
About this record

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.

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