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Assisted reproduction microtool - ARTG 475830

Access comprehensive regulatory information for Assisted reproduction microtool in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 475830 and sponsored by Origio Australasia Pty Ltd, manufactured by CooperSurgical Inc in United States of America. The device registration started on January 15, 2025.

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 475830
Class IIa
Assisted reproduction microtool
ARTG ID: 475830
Good Name: Origio Australasia Pty Ltd - Assisted reproduction microtool
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Intended Purpose

Intended for denudation of oocytes or handling of Cumulus-Oocyte-Complexes (COCs), oocytes, embryos, or biopsied cells during Assisted Reproductive Technology (ART) laboratory procedures. Applied in ART treatments and intended for denudation, i.e. to remove the cumulus from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling oocytes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm).

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
475830
Start Date
January 15, 2025
Effective Date
January 15, 2025
Manufacturer
Country
United States of America
Address
95 Corporate Drive, Trumbull, Connecticut, 06611