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Speculum, rectal

Access comprehensive regulatory information for Speculum, rectal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by InstruMED, manufactured by InstruMED in Australia. The device registration started on July 01, 2018.

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
Speculum, rectal
Australia TGA ARTG Registered Device
Good Name: InstruMED - Speculum, rectal
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Intended Purpose

A surgical instrument which comprises two arms joined at a pivot point, and which is available in various sizes, shapes and contours. It has a blunt distal tip and is used to expand or stretch the rectal orifice/canal when inserted and opened. It is used for examination or the insertion of other instrumentation. It is usually made of stainless steel. The portion of the arms proximal to the pivot point usually form the handle of the device while those distal to the pivot point open when force is exerted.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 01, 2018
Effective Date
July 01, 2018
Sponsor
Manufacturer
Country
Australia
Address
245 South Road, Mile End, SA, 5031