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Moist Heat Pack - Eye heat therapy pack - ARTG 377295

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 registered under ARTG number 377295 and 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.

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Class I
ARTG 377295
Class I
Moist Heat Pack - Eye heat therapy pack
ARTG ID: 377295
Good Name: Meimask - Moist Heat Pack - Eye heat therapy pack
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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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
377295
Start Date
November 02, 2021
Effective Date
November 02, 2021
Sponsor
Manufacturer
Country
China
Address
No 6-10 A5 Shandong International Tech Park South Waihuan Road Linyi, Shandong, 276017