Australia TGA ARTG record

Vitrectomy system micro-cutting unit

Australia TGA ARTG Registered Device · Insight Surgical · Aktive S.R.L. · Class IIa · Started October 01, 2019

Good Name: Insight Surgical - Vitrectomy system micro-cutting unit

Device classification

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

Registration information

Start Date: October 01, 2019
Effective Date: October 01, 2019

Sponsor

Name: Insight Surgical

Manufacturer

Name: Aktive S.R.L.
Country: Italy
Address: 106 Via Giacomo Delitala, Roma, RM, 00173

Intended purpose

A sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove vitreous humour during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and is used with the irrigation/suction systems (separately provided) needed to supply replacement fluid and remove debris. This is a single-use device.

About this record

Access comprehensive regulatory information for Vitrectomy system micro-cutting unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Insight Surgical, manufactured by Aktive S.R.L. in Italy. The device registration started on October 01, 2019.

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.