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GamCath Double-lumen Catheter Kit - Haemodialysis catheter, nonimplantable

Access comprehensive regulatory information for GamCath Double-lumen Catheter Kit - Haemodialysis catheter, nonimplantable 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 18, 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 Double-lumen Catheter Kit - Haemodialysis catheter, nonimplantable
Australia TGA ARTG Registered Device
Good Name: Vantive Pty Ltd - GamCath Double-lumen Catheter Kit - Haemodialysis catheter, nonimplantable
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Intended Purpose

GamCath Dialysis Catheter Kits are used to obtain vascular access to perform extracorporeal blood purification. They consist of its main component, a GamCath Dialysis Catheter, and various accessories, that are used to insert the Catheter into the subclavian, jugular or femoral vein.

Device Classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 18, 2024
Effective Date
April 18, 2024
Sponsor
Manufacturer
Country
Switzerland
Address
Thurgauerstrasse 130, Glattpark, Opfikon, 8152