Australia TGA ARTG record

Cervical dilator, fixed-size

Australia TGA ARTG Registered Device · InstruMED · Elcon Medical Instruments GmbH · Class I · Started June 29, 2018

Good Name: InstruMED - Cervical dilator, fixed-size

Device classification

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

Registration information

Start Date: June 29, 2018
Effective Date: June 29, 2018

Sponsor

Name: InstruMED

Manufacturer

Name: Elcon Medical Instruments GmbH
Country: Germany
Address: Dr Karl-Storz-strasse 26A , Tuttlingen, 78532

Intended purpose

A hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. It typically consists of a slender hollow or solid body instrument in a cylindrical form. It is available in a variety of sizes (diameters) and flexibilities. This is a reusable device.

About this record

Access comprehensive regulatory information for Cervical dilator, fixed-size in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by InstruMED, manufactured by Elcon Medical Instruments GmbH in Germany. The device registration started on June 29, 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.