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Surgical staple loading unit, cutting - ARTG 476669

Access comprehensive regulatory information for Surgical staple loading unit, cutting in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476669 and sponsored by Sungo Australia Pty Ltd, manufactured by Golden Stapler Surgical Co Ltd in China. The device registration started on January 24, 2025.

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 476669
Class IIb
Surgical staple loading unit, cutting
ARTG ID: 476669
Good Name: Sungo Australia Pty Ltd - Surgical staple loading unit, cutting
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Intended Purpose

The Single Patient Use Endo Cutter Reload is intended to be used in conjunction with the single patient use endo cutter, applies to the resection, transection of tissues and creation of anastomosis of tissues in abdominal, gynecological, paediatric and pulmonary laparoscopic/endoscopic surgical procedures (except for central circulatory system).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
476669
Start Date
January 24, 2025
Effective Date
January 24, 2025
Manufacturer
Country
China
Address
Unit B 26 Huashan Zhong Road, Changzhou, Jiangsu, 213022