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Ophthalmic fibreoptic-light instrument, single-use

Access comprehensive regulatory information for Ophthalmic fibreoptic-light instrument, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Spectrum Surgical Pty Ltd, manufactured by France Chirurgie Instrumentation SAS (FCI S.A.S) in France. The device registration started on August 31, 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Ophthalmic fibreoptic-light instrument, single-use
Australia TGA ARTG Registered Device
Good Name: Spectrum Surgical Pty Ltd - Ophthalmic fibreoptic-light instrument, single-use
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Intended Purpose

This instrument is inserted into the eye to illuminate the posterior cavity.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 31, 2023
Effective Date
August 31, 2023
Manufacturer
Country
France
Address
20-22 rue Louis Armand, Paris, 75015