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Ophthalmic cryosurgical system, electronic - ARTG 452325

Access comprehensive regulatory information for Ophthalmic cryosurgical system, electronic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 452325 and sponsored by Paragon Care Group Australia Pty Ltd trading as Designs for Vision, manufactured by Keeler Ltd in United Kingdom. The device registration started on June 16, 2024.

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 IIa
ARTG 452325
Class IIa
Ophthalmic cryosurgical system, electronic
ARTG ID: 452325
Good Name: Paragon Care Group Australia Pty Ltd trading as Designs for Vision - Ophthalmic cryosurgical system, electronic
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Intended Purpose

Keeler Cryomatic probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
452325
Start Date
June 16, 2024
Effective Date
June 16, 2024
Manufacturer
Country
United Kingdom
Address
Clewer Hill Road, Windsor, Berkshire, SL4 4AA