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Measuring instrument, universal instrument

Access comprehensive regulatory information for Measuring instrument, universal instrument in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Minimax Implant Pty Ltd, manufactured by Integration Diagnostics Sweden AB in Sweden. The device registration started on July 28, 2016.

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 IIa
Class IIa
Measuring instrument, universal instrument
Australia TGA ARTG Registered Device
Good Name: Minimax Implant Pty Ltd - Measuring instrument, universal instrument
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Intended Purpose

Penguin RFA is indicated for measuring the stability of dental implants in the oral cavity or craniofacial region. Penguin RFA can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The implant treatment decisions are the responsibility of the surgeon. The instrument is intended for measuring the implant stability on patients that has one or more such implants installed.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 28, 2016
Effective Date
July 28, 2016
Manufacturer
Country
Sweden
Address
Nedergardsgatan 5, Goteborg, 416 54