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Ophthalmic Optical Coherence Tomography Systems - Retinal optical coherence tomography system - ARTG 461939

Access comprehensive regulatory information for Ophthalmic Optical Coherence Tomography Systems - Retinal optical coherence tomography system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 461939 and sponsored by Spectrum Surgical Pty Ltd, manufactured by TowardPi (Shanghai) Medical Technology Ltd in China. The device registration started on September 04, 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 IIa
ARTG 461939
Class IIa
Ophthalmic Optical Coherence Tomography Systems - Retinal optical coherence tomography system
ARTG ID: 461939
Good Name: Spectrum Surgical Pty Ltd - Ophthalmic Optical Coherence Tomography Systems - Retinal optical coherence tomography system
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DJ Fang

DJ Fang

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Intended Purpose

The system is an ophthalmic optical coherence tomography system, which is intended for the in vivo cross sectional and three-dimentional imaging and measurement of ocular tissue, and non-invasive visualization of ocular vasculature based on OCT angiography (OCTA).

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
461939
Start Date
September 04, 2024
Effective Date
September 04, 2024
Manufacturer
Country
China
Address
Room 261 Building 147 No500 Zhennan Road, Putuo District, Shanghai, 200331