Australia TGA ARTG record

Endoscopic electrosurgical/microwave handpiece/electrode/submucosal lift needle set

Australia TGA ARTG Registered Device · CK Surgitech Pty Ltd · Creo Medical Limited · Class IIb · Started November 27, 2018

Good Name: CK Surgitech Pty Ltd - Endoscopic electrosurgical/microwave handpiece/electrode/submucosal lift needle set

Device classification

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

Registration information

Start Date: November 27, 2018
Effective Date: November 27, 2018

Sponsor

Name: CK Surgitech Pty Ltd

Manufacturer

Name: Creo Medical Limited
Country: United Kingdom
Address: Creo House Unit 2 Beaufort Park, Beaufort Park Way, Chepstow, NP165UH

Intended purpose

Speedboat RS2 is intended for use in the cutting and coagulation of soft tissue, and the delivery and injection of fluid solutions, as required or encountered in endoscopic surgical procedures for the removal of pre-cancerous and superficial colorectal epithelial and mucosal lesions.

About this record

Access comprehensive regulatory information for Endoscopic electrosurgical/microwave handpiece/electrode/submucosal lift needle set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by CK Surgitech Pty Ltd, manufactured by Creo Medical Limited in United Kingdom. The device registration started on November 27, 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.