Pure Global

The Histofreezer® STAT Cryosurgical System - Cryosurgical unit, general-purpose - ARTG 380474

Access comprehensive regulatory information for The Histofreezer® STAT Cryosurgical System - Cryosurgical unit, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 380474 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by CryoConcepts LP in United States of America. The device registration started on December 09, 2021.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 380474
Class IIa
The Histofreezer® STAT Cryosurgical System - Cryosurgical unit, general-purpose
ARTG ID: 380474
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - The Histofreezer® STAT Cryosurgical System - Cryosurgical unit, general-purpose
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

This device is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the typical lesions that can be treated Verruca Seborrheic Keratoses Achrochordon Age spots Small Keloids Porokeratosis Angiomas Keratoacanthoma Lentigo Discrete Epithelial Nevus Granuloma Pyogenicum Plantar Warts Actinic Keratoses Molluscum Contagiosum Dermafibroma Granuloma Annulare Lentigo Maligna Bowen’s Disease Chondrodermatitis Leukoplakia Pyogenic Granuloma

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
380474
Start Date
December 09, 2021
Effective Date
December 09, 2021
Manufacturer
Country
United States of America
Address
1100 Conroy Place, Easton, PA, 18040