Australia TGA ARTG record

Cellvizio® F400 v2 system (Laser Scanning Unit / LSU) - Light source/processing unit, endoscope

Australia TGA ARTG Registered Device · Medical Technologies Aust Pty Ltd · Mauna Kea Technologies · Class IIa · Started March 18, 2013

Good Name: Medical Technologies Aust Pty Ltd - Cellvizio® F400 v2 system (Laser Scanning Unit / LSU) - Light source/processing unit, endoscope

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: March 18, 2013
Effective Date: March 18, 2013

Sponsor

Name: Medical Technologies Aust Pty Ltd

Manufacturer

Name: Mauna Kea Technologies
Country: France
Address: 9 rue d'Enghien, Paris, 75010

Intended purpose

Cellvizio® and Cellvizio® 100 Series when used with Confocal Miniprobes are intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal or respiratory or urinary, accessed through an endoscope or endoscopic accessories.

About this record

Access comprehensive regulatory information for Cellvizio® F400 v2 system (Laser Scanning Unit / LSU) - Light source/processing unit, endoscope in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Medical Technologies Aust Pty Ltd, manufactured by Mauna Kea Technologies in France. The device registration started on March 18, 2013.

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.