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Surgical instrument washer/disinfector (chemical/thermal) - ARTG 442430

Access comprehensive regulatory information for Surgical instrument washer/disinfector (chemical/thermal) in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 442430 and sponsored by Henry Schein Halas, manufactured by Dent4You AG in Switzerland. The device registration started on February 26, 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 442430
Class IIb
Surgical instrument washer/disinfector (chemical/thermal)
ARTG ID: 442430
Good Name: Henry Schein Halas - Surgical instrument washer/disinfector (chemical/thermal)
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Intended Purpose

Designed for use by healthcare professionals to clean, or clean and thermally disinfect, (depending on the cycle chosen) general dental and medical instruments. It is designed in accordance with ISO 15883-1 and -2, the international standard for washer-disinfectors, and complements autoclaves by quickly and hygienically preparing soiled instruments for sterilization.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
442430
Start Date
February 26, 2024
Effective Date
February 26, 2024
Manufacturer
Country
Switzerland
Address
Bahnhofstrasse 2, Heerbrugg, CH-9435