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Baldus double mask system - Dental anaesthesia system - ARTG 294881

Access comprehensive regulatory information for Baldus double mask system - Dental anaesthesia system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 294881 and sponsored by Alldent Pty Ltd, manufactured by Baldus Sedation GmbH & Co KG in Germany. The device registration started on October 10, 2017.

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 IIb
ARTG 294881
Class IIb
Baldus double mask system - Dental anaesthesia system
ARTG ID: 294881
Good Name: Alldent Pty Ltd - Baldus double mask system - Dental anaesthesia system
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Intended Purpose

This is a device that is intended to be used for regulating and administration of the flow of medical Nitrous Oxide and Medical Oxygen from a gas supply to a patient for the purpose of conscious sedation analgesia during dental surgical treatment.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
294881
Start Date
October 10, 2017
Effective Date
October 10, 2017
Sponsor
Manufacturer
Country
Germany
Address
In der Langfuhr 32, Bendorf, 56170