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RAY 98 ( M), RAY98(W) R AY 98 (P) POCT 22 Diagnostic X ray Equipment - Stationary intraoral dental x-ray system, analogue - ARTG 466065

Access comprehensive regulatory information for RAY 98 ( M), RAY98(W) R AY 98 (P) POCT 22 Diagnostic X ray Equipment - Stationary intraoral dental x-ray system, analogue in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 466065 and sponsored by Gunz Dental, manufactured by Ningbo Runyes Medical Instrument Co Ltd in China. The device registration started on October 28, 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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TGA ARTG Official Data
Class IIb
ARTG 466065
Class IIb
RAY 98 ( M), RAY98(W) R AY 98 (P) POCT 22 Diagnostic X ray Equipment - Stationary intraoral dental x-ray system, analogue
ARTG ID: 466065
Good Name: Gunz Dental - RAY 98 ( M), RAY98(W) R AY 98 (P) POCT 22 Diagnostic X ray Equipment - Stationary intraoral dental x-ray system, analogue
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Intended Purpose

This is a stationary device that produces a radiation source that is intended to be used as a diagnostic dental x-ray system during dental procedures in the mouth.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
466065
Start Date
October 28, 2024
Effective Date
October 28, 2024
Sponsor
Manufacturer
Country
China
Address
032 Building No 456 Tonghui Road Jiangbei Investment & Pioneering Park C, Ningbo, 315033