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

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.

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Class IIb
Class IIb
Endoscopic electrosurgical/microwave handpiece/electrode/submucosal lift needle set
Australia TGA ARTG Registered Device
Good Name: CK Surgitech Pty Ltd - Endoscopic electrosurgical/microwave handpiece/electrode/submucosal lift needle set
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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.

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
Manufacturer
Country
United Kingdom
Address
Creo House Unit 2 Beaufort Park, Beaufort Park Way, Chepstow, NP165UH