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EXTRA SAFE Percutaneous dilator sheaths - Fascial tissue dilator, single-use

Access comprehensive regulatory information for EXTRA SAFE Percutaneous dilator sheaths - Fascial tissue dilator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Life Systems Medical Pty Ltd, manufactured by Fiab Spa in Italy. The device registration started on January 25, 2023.

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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TGA ARTG Official Data
Class III
Class III
EXTRA SAFE Percutaneous dilator sheaths - Fascial tissue dilator, single-use
Australia TGA ARTG Registered Device
Good Name: Life Systems Medical Pty Ltd - EXTRA SAFE Percutaneous dilator sheaths - Fascial tissue dilator, single-use
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Intended Purpose

EXTRA SAFE sheaths are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 25, 2023
Effective Date
January 25, 2023
Manufacturer
Country
Italy
Address
Via P Costoli 4, Vicchio, Firenze, 50039