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SATURNE II Dual Mobility Liner A.X.P.E - Non-constrained polyethylene acetabular liner - ARTG 401502

Access comprehensive regulatory information for SATURNE II Dual Mobility Liner A.X.P.E - Non-constrained polyethylene acetabular liner in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 401502 and sponsored by Amplitude Australia Pty Ltd, manufactured by Amplitude in France. The device registration started on December 22, 2022.

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
ARTG 401502
Class III
SATURNE II Dual Mobility Liner A.X.P.E - Non-constrained polyethylene acetabular liner
ARTG ID: 401502
Good Name: Amplitude Australia Pty Ltd - SATURNE II Dual Mobility Liner A.X.P.E - Non-constrained polyethylene acetabular liner
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Intended Purpose

SATURNE II dual mobility liner A.X.P.E is intended for use as an acetabular component of total hip replacement to reduce pain and restore joint mobility, in cases of:

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
401502
Start Date
December 22, 2022
Effective Date
December 22, 2022
Manufacturer
Country
France
Address
11 Cours Jacques Offenbach ZA Mozart 2, Valence, 26000