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Fior N Gentz Orthotic Components - Orthosis, leg, ankle/foot, unit

Access comprehensive regulatory information for Fior N Gentz Orthotic Components - Orthosis, leg, ankle/foot, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Massons Healthcare, manufactured by Fior & Gentz in Germany. The device registration started on July 19, 2019.

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
Class I
Fior N Gentz Orthotic Components - Orthosis, leg, ankle/foot, unit
Australia TGA ARTG Registered Device
Good Name: Massons Healthcare - Fior N Gentz Orthotic Components - Orthosis, leg, ankle/foot, unit
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Intended Purpose

Lower limb componentry and Knee and Ankle joints used in the manufacture of custom made AFO, KAFO and knee braces, used in the treatment to control the ankle and or knee joint for numerous patholgies including Stroke, Paraplegia, Multiple sclerosis, cerabral palsy and other neurological patholgies to provide stability and safety to the lower limb when ambulating.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 19, 2019
Effective Date
July 19, 2019
Manufacturer
Country
Germany
Address
Stresemannstrasse 6, Luneburg, D-21335