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GamCath Single-Lumen Dialysis Catheter Kit - Single-lumen haemodialysis catheter, peripheral vascular

Access comprehensive regulatory information for GamCath Single-Lumen Dialysis Catheter Kit - Single-lumen haemodialysis catheter, peripheral vascular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Vantive Pty Ltd, manufactured by Baxter Healthcare SA in Switzerland. The device registration started on April 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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Class III
Class III
GamCath Single-Lumen Dialysis Catheter Kit - Single-lumen haemodialysis catheter, peripheral vascular
Australia TGA ARTG Registered Device
Good Name: Vantive Pty Ltd - GamCath Single-Lumen Dialysis Catheter Kit - Single-lumen haemodialysis catheter, peripheral vascular
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Intended Purpose

GamCath Dialysis Catheters are intended for the short-term (up to 30 days) modification of subclavian, jugular, or femoral veins to obtain vascular access and for the short-term (up to 30 days) treatment by extracorporeal blood purification methods such as apheresis, autotransfusion, hemodialysis, hemofiltration, hemodiafiltration, plasmapheresis, or extracorporeal carbon dioxide removal in combination with extracorporeal blood purification devices and their accessories.

Device Classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 07, 2024
Effective Date
April 07, 2024
Sponsor
Manufacturer
Country
Switzerland
Address
Thurgauerstrasse 130, Glattpark, Opfikon, 8152