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Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated - ARTG 458833

Access comprehensive regulatory information for Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 458833 and sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Europe NV in Belgium. The device registration started on August 07, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class III
ARTG 458833
Class III
Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated
ARTG ID: 458833
Good Name: Terumo Australia Pty Ltd - Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated
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Intended Purpose

Ultimaster Nagomi Sirolimus eluting coronary stent system is intended to improve myocardial blood flow in patients with stenotic or occlusive lesions in coronary arteries. The stent is indicated (but not limited) to treat patients with chronic coronary syndrome, acute coronary syndrome (STEMI, NSTEMI & unstable angina), diabetes mellitus, multivessel disease, bifurcation lesions, patients older than 65 years, male & female, patients with totally occluded lesions, long lesions, lesions residing in small coronary vessels, restenotic lesions including in-stent restenosis, ostial lesions, lesions in left main coronary artery & arterial or venous bypass graft. Suitable for both femoral & radial approach.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
458833
Start Date
August 07, 2024
Effective Date
August 07, 2024
Manufacturer
Country
Belgium
Address
Interleuvenlaan 40, Leuven, 3001