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Medical equipment drape, single-use - ARTG 422332

Access comprehensive regulatory information for Medical equipment drape, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 422332 and sponsored by Constar X Pty Ltd, manufactured by Henan Robestain Medical Products Co Ltd in China. The device registration started on September 25, 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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TGA ARTG Official Data
Class Is
ARTG 422332
Class Is
Medical equipment drape, single-use
ARTG ID: 422332
Good Name: Constar X Pty Ltd - Medical equipment drape, single-use
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Intended Purpose

A sterile single use device intended to cover/wrap the C-arm fluoroscopic x-ray system or patient / operating table and function as a physical barrier to prevent cross-contamination between the covered item and the surgical staff/field during a procedure.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
422332
Start Date
September 25, 2023
Effective Date
September 25, 2023
Manufacturer
Country
China
Address
No 590 Zhangnan Industry Zone Zhangsanzhai Town, Changyuan County, Henan Province