Australia TGA ARTG record

Syringe, irrigating, general-purpose

Australia TGA ARTG Registered Device · Tollot Pty Ltd T/a Aaxis Pacific · Hangzhou Primecare Medical Co Ltd · Class Is · Started July 15, 2021

Good Name: Tollot Pty Ltd T/a Aaxis Pacific - Syringe, irrigating, general-purpose

Device classification

Risk Class: Class Is
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 15, 2021
Effective Date: July 15, 2021

Sponsor

Name: Tollot Pty Ltd T/a Aaxis Pacific

Manufacturer

Name: Hangzhou Primecare Medical Co Ltd
Country: China
Address: Room 408-409 Zancheng Center West, Shangcheng Distrcit, Hangzhou, 310008

Intended purpose

The device is intended to be used to fill a urinary catheter balloon with an irrigating solution. The device is supplied sterile, and is single use.

About this record

Access comprehensive regulatory information for Syringe, irrigating, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Tollot Pty Ltd T/a Aaxis Pacific, manufactured by Hangzhou Primecare Medical Co Ltd in China. The device registration started on July 15, 2021.

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.