Australia TGA ARTG record

Protective mouthguard, <specify>

Australia TGA ARTG Registered Device · Henry Schein Halas · Directa AB · Class I · Started December 10, 2021

Good Name: Henry Schein Halas - Protective mouthguard, <specify>

Device classification

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

Registration information

Start Date: December 10, 2021
Effective Date: December 10, 2021

Sponsor

Name: Henry Schein Halas

Manufacturer

Name: Directa AB
Country: Sweden
Address: Finvids vag 8, Upplands Vasby, SE-194 27

Intended purpose

This dievice helps protect teeth from damages caused by instrument in connection with peroral endoscopy or intubation or heavily biting in connection with ECT

About this record

Access comprehensive regulatory information for Protective mouthguard, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Henry Schein Halas, manufactured by Directa AB in Sweden. The device registration started on December 10, 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.