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Scalpel, one-piece, single use

Australia TGA ARTG Registered Device · Erskine Products Pty Ltd · Huaian Tianda Medical Instruments Co Ltd · Class IIa · Started September 28, 2021

Good Name: Erskine Products Pty Ltd - Scalpel, one-piece, single use

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
September 28, 2021
Effective Date
September 28, 2021
Sponsor
Manufacturer
Country
China
Address
No 106 East Songjiang Road Huaiyin Economic & Technological Development Zone, Huaian City, Jiangsu, 223002
Intended purpose

A sterile, hand-operated surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by a physician to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.

About this record

Access comprehensive regulatory information for Scalpel, one-piece, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Erskine Products Pty Ltd, manufactured by Huaian Tianda Medical Instruments Co Ltd in China. The device registration started on September 28, 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.

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