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Cervical dilator, expandable, hydroscopic laminaria

Access comprehensive regulatory information for Cervical dilator, expandable, hydroscopic laminaria in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Basin Medical Pty Ltd, manufactured by Medgyn Products Inc in United States of America. The device registration started on July 12, 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Cervical dilator, expandable, hydroscopic laminaria
Australia TGA ARTG Registered Device
Good Name: Basin Medical Pty Ltd - Cervical dilator, expandable, hydroscopic laminaria
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Intended Purpose

A sterile material designed to dilate (stretch open) the cervical canal after inserting it into the cervical os. It is made from the root of seaweed (laminaria digitata) and slowly expands as it absorbs moisture (usually 6 to 24 hours). It may be used to dilate the cervical canal for uterine curettage, labour induction, intrauterine device (IUD) placement and removal, and radium placement. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 12, 2024
Effective Date
July 12, 2024
Manufacturer
Country
United States of America
Address
800 Pasquinelli Drive, Westmont, Illinois, 60559