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Computed radiography storage phosphor screen

Access comprehensive regulatory information for Computed radiography storage phosphor screen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Acteon Australia/New Zealand, manufactured by PaloDEx Group Oy in Finland. The device registration started on February 10, 2023.

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
Computed radiography storage phosphor screen
Australia TGA ARTG Registered Device
Good Name: Acteon Australia/New Zealand - Computed radiography storage phosphor screen
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Intended Purpose

This is a device an imaging plate that is temporarily placed in the mouth that is intended to be used with a diagnostic imaging extra oral x-ray system to record a patient anatomy in the mouth during dental procedures

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 10, 2023
Effective Date
February 10, 2023
Manufacturer
Country
Finland
Address
Nahkelantie 160, Tuusula, FI 04300