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Transducer cartridges - Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal

Australia TGA ARTG Registered Device · Classys Australia Pty Ltd · Classys Inc · Class IIa · Started June 16, 2023

Good Name: Classys Australia Pty Ltd - Transducer cartridges - Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
June 16, 2023
Effective Date
June 16, 2023
Sponsor
Manufacturer
Country
South Korea
Address
CLASSYS 208 Teheran-ro Gangnam-gu, Seoul
Intended purpose

Ultraformer transducer cartridges are to be used with the Focused ultrasound therapeutic equipment systems to deliver high intensity focused ultrasound (HIFU) to provide non-surgical skin lifting and tightening.

About this record

Access comprehensive regulatory information for Transducer cartridges - Transducer assembly, ultrasound, therapeutic, hyperthermia, extracorporeal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Classys Australia Pty Ltd, manufactured by Classys Inc in South Korea. The device registration started on June 16, 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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