ARTG 334568

Public N95 respirator

ARTG ID: 334568 · Dalcross Medical Equipment · Makrite Industries Inc. · Class I · Started April 18, 2020

Good Name: Dalcross Medical Equipment - Public N95 respirator

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

ARTG ID: 334568
Start Date: April 18, 2020
Effective Date: April 18, 2020

Sponsor

Name: Dalcross Medical Equipment

Manufacturer

Name: Makrite Industries Inc.
Country: Taiwan
Address: 11F-5 No 79 Sec 1 Xin Tai 5th Road, Xizhi District, New Taipei City

Intended purpose

A filtering mask [N95 (filter efficiency 95%)] designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency (e.g., influenza pandemic). It is typically made of multiple layers of non-woven polymers, and incorporates a forming nosepiece (metal wire); it is typically secured using elastic head straps. This is a single-use device.

About this record

Access comprehensive regulatory information for Public N95 respirator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 334568 and sponsored by Dalcross Medical Equipment, manufactured by Makrite Industries Inc. in Taiwan. The device registration started on April 18, 2020.

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.