Pure Global

Protective mouthguard, <specify>

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.

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TGA ARTG Official Data
Class I
Class I
Protective mouthguard, <specify>
Australia TGA ARTG Registered Device
Good Name: Henry Schein Halas - Protective mouthguard, <specify>
Pure Global
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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

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
Manufacturer
Country
Sweden
Address
Finvids vag 8, Upplands Vasby, SE-194 27