Australia TGA ARTG record

Laparoscopic electrosurgical scissors

Australia TGA ARTG Registered Device · Sonita Medic Enterprises Pty Ltd · Hangzhou Optcla Medical Instrument Co Ltd · Class IIb · Started January 16, 2018

Good Name: Sonita Medic Enterprises Pty Ltd - Laparoscopic electrosurgical scissors

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 16, 2018
Effective Date: January 16, 2018

Sponsor

Name: Sonita Medic Enterprises Pty Ltd

Manufacturer

Name: Hangzhou Optcla Medical Instrument Co Ltd
Country: China
Address: No.2 Fengxiang Road Economic Development Zone Tonglu Hangzhou, Zhejiang , 311508

Intended purpose

A sterile, rigid, electrosurgical laparoscopic device designed to perform through a compatible laparoscopic instrument (e.g., an access port) and to be connected to an electrosurgical diathermy generator when required to provide electrical current, to cut, coagulate, and transect tissue accessible via the abdominal cavity. This is a single-use device.

About this record

Access comprehensive regulatory information for Laparoscopic electrosurgical scissors in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Sonita Medic Enterprises Pty Ltd, manufactured by Hangzhou Optcla Medical Instrument Co Ltd in China. The device registration started on January 16, 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.