Pure Global

Digital imaging cassette/storage phosphor screen, dental - ARTG 389033

Access comprehensive regulatory information for Digital imaging cassette/storage phosphor screen, dental in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 389033 and sponsored by Durr Dental Oceania Pty Ltd, manufactured by Durr Dental SE in Germany. The device registration started on May 24, 2022.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 389033
Class I
Digital imaging cassette/storage phosphor screen, dental
ARTG ID: 389033
Good Name: Durr Dental Oceania Pty Ltd - Digital imaging cassette/storage phosphor screen, dental
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

This is a barrier envelope that is intended to be used to hold and shield an attached phosphor storage screen (mounted on a phosphor storage plate (PSP)) from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
389033
Start Date
May 24, 2022
Effective Date
May 24, 2022
Manufacturer
Country
Germany
Address
Hopfigheimer Str 17, Bietigheim-Bissingen, 74321