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BI-MENTUM Dual Mobility System Plus Cementless Acetabular Cup - Acetabular shell - ARTG 363132

Access comprehensive regulatory information for BI-MENTUM Dual Mobility System Plus Cementless Acetabular Cup - Acetabular shell in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 363132 and sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Serf in France. The device registration started on April 23, 2021.

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 III
ARTG 363132
Class III
BI-MENTUM Dual Mobility System Plus Cementless Acetabular Cup - Acetabular shell
ARTG ID: 363132
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - BI-MENTUM Dual Mobility System Plus Cementless Acetabular Cup - Acetabular shell
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Intended Purpose

Acetabular cups combining a "Plus Cup" and a "PE Liner" are intended for the treatment of the following conditions: osteoarthritis of the hip, osteonecrosis, surgical revision (including recurrent dislocation and loosening) if the bone reconstruction allows, Paprosky type I, IIA and IIC bone defects.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
363132
Start Date
April 23, 2021
Effective Date
April 23, 2021
Manufacturer
Name
Serf
Country
France
Address
85 Avenue des Bruyeres, Decines, 69153