Australia TGA ARTG recordMask, surgical, single use
Australia TGA ARTG Registered Device · Dexcon Pty Ltd · Tecomen Technology Co Ltd · Class I · Started September 16, 2020
Good Name: Dexcon Pty Ltd - Mask, surgical, single use
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- September 16, 2020
- Effective Date
- September 16, 2020
- Name
- Dexcon Pty Ltd
- Country
- Vietnam
- Address
- Tu Ho Hamlet Yen Phu Commune Yen My District, Hung Yen Province
Product description: single use Three ply medical (Type II) Level 2 face mask with elastic ear loop. The purpose of the products are to stop the transmission of bacterial virus pollen into humans respiratory system. productions are made by two outer layers of non-woven with middle layer of 98% filtration rate melt blown fabric. Products are made to comply Australia standards 4381:2015, and are classify as Level 2 (Type II) barrier medical face mask. Materials are evaluated for resistance to penetration by synthetic blood at the maximum velocity, bacterial filtration efficiency and differential pressure. Certificate of original of the products can be provided by the manufacture. international certificate such as CE, FDA can also be provided. Test report of above index can also be provided.
Access comprehensive regulatory information for Mask, surgical, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Dexcon Pty Ltd, manufactured by Tecomen Technology Co Ltd in Vietnam. The device registration started on September 16, 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.