Australia TGA ARTG recordEndoscopic biopsy valve, non-sterile
Australia TGA ARTG Registered Device · CK Surgitech Pty Ltd · Changzhou Endoclean Medical Device Co Ltd · Class IIa · Started November 12, 2020
Good Name: CK Surgitech Pty Ltd - Endoscopic biopsy valve, non-sterile
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 12, 2020
- Effective Date
- November 12, 2020
- 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
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.
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.