Australia TGA ARTG record

Light source, hand-held, battery powered

Australia TGA ARTG Registered Device · Hallmark Surgical Ltd · Orion Concepts Inc · Class I · Started May 31, 2024

Good Name: Hallmark Surgical Ltd - Light source, hand-held, battery powered

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

Name: Hallmark Surgical Ltd

Manufacturer

Name: Orion Concepts Inc
Country: Canada
Address: 2-451 Enfield Road, Burlington, ON, L7T 2X5

Intended purpose

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

About this record

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.