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Blade, scalpel, single use - ARTG 320383

Access comprehensive regulatory information for Blade, scalpel, 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 320383 and sponsored by Ultra Health Medical Pty Ltd, manufactured by Paramount Surgimed Ltd in India. The device registration started on July 18, 2019.

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
ARTG 320383
Class IIa
Blade, scalpel, single use
ARTG ID: 320383
Good Name: Ultra Health Medical Pty Ltd - Blade, scalpel, single use
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Intended Purpose

The sharps component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is a sterile disposable invasive surgical device. The Surgical blade is made of a sterilised high grade stainless steel alloy or carbon steel alloy. the blade is sterilised by gamma radiation. The surgical blades are single use only.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
320383
Start Date
July 18, 2019
Effective Date
July 18, 2019
Manufacturer
Country
India
Address
HO 1 LSC Okhla Industrial Area, Phase - II, New Delhi India, 110 020