Australia TGA ARTG record

Skin microbial sealant

Australia TGA ARTG Registered Device · Surgical Specialties Pty Ltd · Advanced Medical Solutions Limited · Class Is · Started March 24, 2023

Good Name: Surgical Specialties Pty Ltd - Skin microbial sealant

Device classification

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

Registration information

Start Date: March 24, 2023
Effective Date: March 24, 2023

Sponsor

Name: Surgical Specialties Pty Ltd

Manufacturer

Name: Advanced Medical Solutions Limited
Country: United Kingdom
Address: Western Wood Way Langage Science Park, Plymouth, Devon, PL7 5BG

Intended purpose

INTEGUSEAL Microbial Sealant is a film forming; cyanoacrylate based microbial sealant provided in a ready to use applicator. INTEGUSEAL Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

About this record

Access comprehensive regulatory information for Skin microbial sealant in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Surgical Specialties Pty Ltd, manufactured by Advanced Medical Solutions Limited in United Kingdom. The device registration started on March 24, 2023.

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.