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Sterilizer, moist heat, wrapped goods - ARTG 433653

Access comprehensive regulatory information for Sterilizer, moist heat, wrapped goods in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 433653 and sponsored by Henry Schein Halas, manufactured by MELAG Medizintechnik GmbH & Co KG in Germany. The device registration started on January 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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Class IIb
ARTG 433653
Class IIb
Sterilizer, moist heat, wrapped goods
ARTG ID: 433653
Good Name: Henry Schein Halas - Sterilizer, moist heat, wrapped goods
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Intended Purpose

Intended for use in the medical sector, e.g. in medical and dental practices. The small steam sterilizer is designed according to EN 13060. It uses the fractionated vacuum process to ensure effective steam penetration of the load with saturated steam. It is suitable for reprocessing instruments and materials that may come into contact with blood or body fluids during treatment. The steam sterilizer is not intended for use on patients or in patient care and is not intended for the sterilization of liquids.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
433653
Start Date
January 12, 2024
Effective Date
January 12, 2024
Manufacturer
Country
Germany
Address
Geneststr 6-10, Berlin, 10829