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Endoscopic manual linear cutting stapler, single-use - ARTG 427083

Access comprehensive regulatory information for Endoscopic manual linear cutting stapler, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 427083 and sponsored by Multigate Medical Products Pty Ltd, manufactured by Fengh Medical Co Ltd in China. The device registration started on October 30, 2023.

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 IIb
ARTG 427083
Class IIb
Endoscopic manual linear cutting stapler, single-use
ARTG ID: 427083
Good Name: Multigate Medical Products Pty Ltd - Endoscopic manual linear cutting stapler, single-use
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Intended Purpose

A sterile, hand-held, manual surgical instrument intended to be used during endoscopic surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. This is a single-use device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427083
Start Date
October 30, 2023
Effective Date
October 30, 2023
Manufacturer
Country
China
Address
D3 No 6 Dongsheng West Road Jiangyin National High-Tech Zone, Jiangsu, 214437