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External pledget - ARTG 484128

Access comprehensive regulatory information for External pledget in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 484128 and sponsored by Bausch & Lomb Australia Pty Ltd, manufactured by Promeia SpA in Italy. The device registration started on March 26, 2025.

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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Class Is
ARTG 484128
Class Is
External pledget
ARTG ID: 484128
Good Name: Bausch & Lomb Australia Pty Ltd - External pledget
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Intended Purpose

Mechanical removal of foreign bodies like ex-sudates, secretions and encrustations from the peri-ocular area, eye lids and eye lashes. Hydration of the zone as secondary action. The device is indicated also as coadjuvant of eventual pharmacological treatments, during pathological inflammations, allergic reactions or before or after eye surgery or laser treatment in order to clean the area.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484128
Start Date
March 26, 2025
Effective Date
March 26, 2025
Manufacturer
Country
Italy
Address
Via Cardinale Ascanio Sforza 85, Milan, 20141