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Orthosis, spinal, sacroiliac, <specify> - ARTG 421011

Access comprehensive regulatory information for Orthosis, spinal, sacroiliac, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 421011 and sponsored by Alpha Vital Pty Ltd, manufactured by Serola Biomechanics Inc in United States of America. The device registration started on September 04, 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 I
ARTG 421011
Class I
Orthosis, spinal, sacroiliac, <specify>
ARTG ID: 421011
Good Name: Alpha Vital Pty Ltd - Orthosis, spinal, sacroiliac, <specify>
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Intended Purpose

An orthosis that encompasses the whole or part of the sacro-iliac region of the trunk worn to help stabilise and support the sacroilliac joint.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
421011
Start Date
September 04, 2023
Effective Date
September 04, 2023
Manufacturer
Country
United States of America
Address
5406 Forest Hills Court, Loves Park, IL, 61111