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Cervical dilator, expandable, hydroscopic laminaria - ARTG 463605

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 registered under ARTG number 463605 and sponsored by Stark Medical, manufactured by MedGyn Products International Inc and MedGyn Products Inc in United States of America. The device registration started on October 03, 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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Class IIa
ARTG 463605
Class IIa
Cervical dilator, expandable, hydroscopic laminaria
ARTG ID: 463605
Good Name: Stark Medical - Cervical dilator, expandable, hydroscopic laminaria
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Intended Purpose

The device is made from the root of seaweed (laminaria digitata) it is used to dilate the cervical canal by slowly expanding as it absorbs moisture for the induction of labour, curettage and drainage of uterine cavity, placement or removal of intrauterine devices.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
463605
Start Date
October 03, 2024
Effective Date
October 03, 2024
Sponsor
Manufacturer
Country
United States of America
Address
100 West Industrial Road, Addison, Illinois, 60101