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Body-orifice ultrasound imaging system transducer cover, image-enhancement - ARTG 462845

Access comprehensive regulatory information for Body-orifice ultrasound imaging system transducer cover, image-enhancement in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 462845 and sponsored by Innologic Pty Ltd, manufactured by Suzhou Leapmed Healthcare Corporation in China. The device registration started on September 25, 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 I
ARTG 462845
Class I
Body-orifice ultrasound imaging system transducer cover, image-enhancement
ARTG ID: 462845
Good Name: Innologic Pty Ltd - Body-orifice ultrasound imaging system transducer cover, image-enhancement
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Intended Purpose

A single use, non-sterile sheath that protects the ultrasound transducer during examinations of natural cavities such as rectum and vagina. It may contain a balloon that when filled, permits improved imaging of the anatomy being examined.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462845
Start Date
September 25, 2024
Effective Date
September 25, 2024
Manufacturer
Country
China
Address
Building 7 No 188 Fuchunjiang Road SND, Suzhou, Jiangsu, 215163