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Scalpel, one-piece, single use

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 Bydand Trading Pty Ltd T/A Bydand Medical, manufactured by Sinapi Biomedical Pty Ltd in South Africa. The device registration started on June 22, 2018.

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
Class IIa
Scalpel, one-piece, single use
Australia TGA ARTG Registered Device
Good Name: Bydand Trading Pty Ltd T/A Bydand Medical - Scalpel, one-piece, single use
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Intended Purpose

This is a sterile, hand-held, manual surgical instrument that is intended to be used by the operator 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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 22, 2018
Effective Date
June 22, 2018
Manufacturer
Country
South Africa
Address
ARC Infruitec North Campus Lelie Road, Stellenbosch, 7600