ARTG 375989Side-notch biopsy gun, single-use
ARTG ID: 375989 · Ultramed · Zhejiang CuraWay Medical Technology Co Ltd · Class IIa · Started October 08, 2021
Good Name: Ultramed - Side-notch biopsy gun, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 375989
- Start Date
- October 08, 2021
- Effective Date
- October 08, 2021
- Name
- Ultramed
- Country
- China
- Address
- Room 106 Building 1 #600 21st Street Economic & Technology Development Area, Hangzhou, Zhejiang, 310018
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/test. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Access comprehensive regulatory information for Side-notch biopsy gun, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 375989 and sponsored by Ultramed, manufactured by Zhejiang CuraWay Medical Technology Co Ltd in China. The device registration started on October 08, 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.