Pure Global

General-body orifice lubricant, sterile

Access comprehensive regulatory information for General-body orifice lubricant, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Petrus Pharmaceuticals Pty Ltd, manufactured by Sion Biotext Medical Ltd in Israel. The device registration started on December 22, 2015.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
Class IIa
General-body orifice lubricant, sterile
Australia TGA ARTG Registered Device
Good Name: Petrus Pharmaceuticals Pty Ltd - General-body orifice lubricant, sterile
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. For gynaecological, urological, medical and surgical use. Suitable in electrotherapy and cytoscopic work and for instrument and digital examinations.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 22, 2015
Effective Date
December 22, 2015
Manufacturer
Country
Israel
Address
3Ha'Eshel St Sapirim Industrial Park, Sderot, Israel, 8701002