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Endoscopic biopsy valve, non-sterile

Access comprehensive regulatory information for Endoscopic biopsy valve, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by CK Surgitech Pty Ltd, manufactured by Changzhou Endoclean Medical Device Co Ltd in China. The device registration started on November 12, 2020.

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 IIa
Class IIa
Endoscopic biopsy valve, non-sterile
Australia TGA ARTG Registered Device
Good Name: CK Surgitech Pty Ltd - Endoscopic biopsy valve, non-sterile
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Intended Purpose

A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 12, 2020
Effective Date
November 12, 2020
Manufacturer
Country
China
Address
West Side of 4th Floor Building E2 West Taihu Medical Industry Incubator Park, No 9 Changyang Road Wujin District, Changzhou City, Jiangsu Province, 213000