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Protective mouthguard, preformed

Access comprehensive regulatory information for Protective mouthguard, preformed in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Precise Medical Supplies Pty Ltd, manufactured by Medasil Surgical Ltd in United Kingdom. The device registration started on May 06, 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 Is
Class Is
Protective mouthguard, preformed
Australia TGA ARTG Registered Device
Good Name: Precise Medical Supplies Pty Ltd - Protective mouthguard, preformed
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Intended Purpose

Intended to be positioned over the teeth prior to, and during, induction of anaesthesia, intubation, or any surgical or diagnostic procedure involving oral access. The device provides protection against accidental damage to any loose teeth, dental features (e.g. caps, crowns, etc) or tissues of the buccopharyngeal area that might result from unintentional or excessive contact with surgical instruments.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 06, 2021
Effective Date
May 06, 2021
Manufacturer
Country
United Kingdom
Address
Medasil House Hunslet Road, Leeds, LS10 1AU