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Cast boot - ARTG 425311

Access comprehensive regulatory information for Cast boot in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 425311 and sponsored by BSN Medical (Aust) Pty Ltd, manufactured by Span Link International LLC in United States of America. The device registration started on October 13, 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 425311
Class I
Cast boot
ARTG ID: 425311
Good Name: BSN Medical (Aust) Pty Ltd - Cast boot
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Intended Purpose

A boot-like cover for a foot enclosed in a leg cast or bulky bandages intended to support postsurgical healing, injury/trauma care or any situation that requires a pressure off-load of the foot. This device has an outer sole for walking, and closures for easy application and removal.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
425311
Start Date
October 13, 2023
Effective Date
October 13, 2023
Manufacturer
Country
United States of America
Address
28 West Jefryn Boulevard Suite C, Deer Park, New York, 11729