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Light source, hand-held, battery powered

Access comprehensive regulatory information for Light source, hand-held, battery powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Hallmark Surgical Ltd, manufactured by Orion Concepts Inc in Canada. The device registration started on May 31, 2024.

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
Light source, hand-held, battery powered
Australia TGA ARTG Registered Device
Good Name: Hallmark Surgical Ltd - Light source, hand-held, battery powered
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Intended Purpose

A Cordless LED light source designed to connect to various instruments to provide illumination. e.g. Sigmoidoscopes, Proctoscopes.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 31, 2024
Effective Date
May 31, 2024
Sponsor
Manufacturer
Country
Canada
Address
2-451 Enfield Road, Burlington, ON, L7T 2X5