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ENFit/ENFit linear connector - ARTG 446350

Access comprehensive regulatory information for ENFit/ENFit linear connector in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 446350 and sponsored by GSE Pty Ltd, manufactured by The Insides Company Limited in New Zealand. The device registration started on April 23, 2024.

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 IIa
ARTG 446350
Class IIa
ENFit/ENFit linear connector
ARTG ID: 446350
Good Name: GSE Pty Ltd - ENFit/ENFit linear connector
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Intended Purpose

THE INSIDESยฎ Neo is intended to channel chyme from an ostomy appliance into the distal limb of a patientโ€™s intestinal tract to help sustain their nutrition and gut health.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
446350
Start Date
April 23, 2024
Effective Date
April 23, 2024
Sponsor
Manufacturer
Country
New Zealand
Address
487 Parnell Road Parnell, Auckland, 1052