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Catheter, Bartholin's gland

Access comprehensive regulatory information for Catheter, Bartholin's gland 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 15, 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
Catheter, Bartholin's gland
Australia TGA ARTG Registered Device
Good Name: Basin Medical Pty Ltd - Catheter, Bartholin's gland
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Intended Purpose

It is typically used for drainage in the treatment of Bartholin's gland cysts or abscesses. This is a single-use item that can be left in place for up to four weeks. The kit includes a balloon catheter, a syringe for balloon inflation, and a scalpel.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
July 15, 2024
Effective Date
July 15, 2024
Manufacturer
Country
United States of America
Address
800 Pasquinelli Drive, Westmont, Illinois, 60559