Australia TGA ARTG record

Moist Heat Pack - Eye heat therapy pack

Australia TGA ARTG Registered Device · Meimask · Koolcare Technology Co Ltd · Class I · Started November 02, 2021

Good Name: Meimask - Moist Heat Pack - Eye heat therapy pack

Device classification

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

Registration information

Start Date: November 02, 2021
Effective Date: November 02, 2021

Sponsor

Name: Meimask

Manufacturer

Name: Koolcare Technology Co Ltd
Country: China
Address: No 6-10 A5 Shandong International Tech Park South Waihuan Road Linyi, Shandong, 276017

Intended purpose

Meimask is an eye heat therapy pack. It is a non sterile device to be placed on closed eyes to heat the eye lids. It is used to treat meibomian gland dysfunction(MGD). It is a mask which contains a removable bead heat pack (beads contain silica, alumina and water) to be heated in a microwave for 15 seconds prior to use. The mask is washable and the bead packs are reusable.

About this record

Access comprehensive regulatory information for Moist Heat Pack - Eye heat therapy pack in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Meimask, manufactured by Koolcare Technology Co Ltd in China. The device registration started on November 02, 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.