Pure Global

Patient positioning device, diagnostic imaging/radiotherapy, moulding, thermoplastic

Access comprehensive regulatory information for Patient positioning device, diagnostic imaging/radiotherapy, moulding, thermoplastic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Rehacare Pty Ltd, manufactured by Kinetec SAS in France. The device registration started on June 03, 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
Patient positioning device, diagnostic imaging/radiotherapy, moulding, thermoplastic
Australia TGA ARTG Registered Device
Good Name: Rehacare Pty Ltd - Patient positioning device, diagnostic imaging/radiotherapy, moulding, thermoplastic
Pure Global
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Intended Purpose

Low temperature thermoplastic material used to create splints/moulds for the patient's body. Supplied as sheets of thermoplastic material for ease of handling and positioning. Materials are softened by heating in hot water and while softened, are moulded around the patient's BODY. When cooled, it hardens to form a custom-made splint to support that part of the body. The splint is secured to the body using velcro straps or a bandage.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 03, 2019
Effective Date
June 03, 2019
Sponsor
Manufacturer
Country
France
Address
Rue Maurice, Perin ZI de Tournes, Tournes, 08090