Australia TGA ARTG record

Speculum, vaginal, single use

Australia TGA ARTG Registered Device · Hallmark Surgical Ltd · IOB Medical Inc · Class Is · Started July 11, 2019

Good Name: Hallmark Surgical Ltd - Speculum, vaginal, single use

Device classification

Risk Class: Class Is
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 11, 2019
Effective Date: July 11, 2019

Sponsor

Name: Hallmark Surgical Ltd

Manufacturer

Name: IOB Medical Inc
Country: United States of America
Address: 504 East Diamond Ave Suite 1, Gaithersburg, MD, 20877

Intended purpose

Disposable Speculum with self contained LED light source for examinations

About this record

Access comprehensive regulatory information for Speculum, vaginal, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Hallmark Surgical Ltd, manufactured by IOB Medical Inc in United States of America. The device registration started on July 11, 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.