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Penguin RFA - Measuring instrument, universal instrument - ARTG 468270

Access comprehensive regulatory information for Penguin RFA - Measuring instrument, universal instrument in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 468270 and sponsored by MG Implant, manufactured by Integration Diagnostics Sweden AB in Sweden. The device registration started on November 12, 2024.

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
ARTG 468270
Class I
Penguin RFA - Measuring instrument, universal instrument
ARTG ID: 468270
Good Name: MG Implant - Penguin RFA - Measuring instrument, universal instrument
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Intended Purpose

The Penguin RFA is intended for use by dental professionals as a non-invasive device to measure implant stability and osseointegration through resonance frequency analysis (RFA). It aids in determining the optimal time for implant loading and contributes to treatment planning by providing quantitative data on implant stability. The device is designed for use in clinical settings and supports both initial implant placement and ongoing assessments during the healing phase.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
468270
Start Date
November 12, 2024
Effective Date
November 12, 2024
Sponsor
Manufacturer
Country
Sweden
Address
Furstenbergsgatan 4, Goteborg, 416 64