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Bag, tissue extraction - ARTG 298691

Access comprehensive regulatory information for Bag, tissue extraction in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 298691 and sponsored by Sonita Medic Enterprises Pty Ltd, manufactured by Hangzhou Optcla Medical Instrument Co Ltd in China. The device registration started on January 18, 2018.

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 IIa
ARTG 298691
Class IIa
Bag, tissue extraction
ARTG ID: 298691
Good Name: Sonita Medic Enterprises Pty Ltd - Bag, tissue extraction
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Intended Purpose

A sterile, endoscopy surgical instrument with attached pouch / bag intended to be used during minimal invasive surgery for the extraction of dissected patient body tissue typically involving keyhole surgery techniques, e.g., laparoscopic surgery. This device can be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, and gall bladder removal. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
298691
Start Date
January 18, 2018
Effective Date
January 18, 2018
Manufacturer
Country
China
Address
No.2 Fengxiang Road Economic Development Zone Tonglu Hangzhou, Zhejiang , 311508