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Speculum, vaginal, single use

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.

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TGA ARTG Official Data
Class Is
Class Is
Speculum, vaginal, single use
Australia TGA ARTG Registered Device
Good Name: Hallmark Surgical Ltd - Speculum, vaginal, single use
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Intended Purpose

Disposable Speculum with self contained LED light source for examinations

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
Manufacturer
Country
United States of America
Address
504 East Diamond Ave Suite 1, Gaithersburg, MD, 20877