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General/multiple surgical laser system beam guide, single-use

Access comprehensive regulatory information for General/multiple surgical laser system beam guide, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Life Healthcare Pty Ltd, manufactured by EMS Electro Medical Systems SA in Switzerland. The device registration started on November 30, 2022.

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 IIb
Class IIb
General/multiple surgical laser system beam guide, single-use
Australia TGA ARTG Registered Device
Good Name: Life Healthcare Pty Ltd - General/multiple surgical laser system beam guide, single-use
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Intended Purpose

Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumours and lesions, complete or partial resection of internal organs, tumours or lesions, tissue vaporization, haemostasis, lithotripsy and/or coagulation may be indicated with an approved compatible laser. Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532-2100 nm, with pulsed & continuous wave(CW) emission modes ie compatible for use with Diode lasers, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed & CW lasers.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 30, 2022
Effective Date
November 30, 2022
Manufacturer
Country
Switzerland
Address
Chemin De La Vuarpilliere 31, NYON, 1260