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Gastrostomy procedure kit - ARTG 462745

Access comprehensive regulatory information for Gastrostomy procedure kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 462745 and sponsored by Fresenius Kabi Australia Pty Ltd, manufactured by Fresenius Kabi AG in Germany. The device registration started on September 25, 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 IIb
ARTG 462745
Class IIb
Gastrostomy procedure kit
ARTG ID: 462745
Good Name: Fresenius Kabi Australia Pty Ltd - Gastrostomy procedure kit
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Intended Purpose

Procedure pack consisting of gastropexy loop fixture, suture material and cotton balls designed to assist with a gastrostomy procedure to fix the stomach to the abdominal wall for percutaneous endoscopic gastrostomy.

Device Classification
Risk Class
Class IIb
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
462745
Start Date
September 25, 2024
Effective Date
September 25, 2024
Manufacturer
Country
Germany
Address
61346, Bad Homburg