Australia TGA ARTG record

Surgical instrument washer/disinfector (chemical/thermal)

Australia TGA ARTG Registered Device · Henry Schein Halas · Dent4You AG · Class IIb · Started February 26, 2024

Good Name: Henry Schein Halas - Surgical instrument washer/disinfector (chemical/thermal)

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: February 26, 2024
Effective Date: February 26, 2024

Sponsor

Name: Henry Schein Halas

Manufacturer

Name: Dent4You AG
Country: Switzerland
Address: Bahnhofstrasse 2, Heerbrugg, CH-9435

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.

About this record

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 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.