Australia TGA ARTG record

General-body orifice lubricant, sterile

Australia TGA ARTG Registered Device · Reynard Health Supplies (Aus) Pty Ltd · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San ve Tic AS · Class IIa · Started August 04, 2021

Good Name: Reynard Health Supplies (Aus) Pty Ltd - General-body orifice lubricant, sterile

Device classification

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

Registration information

Start Date: August 04, 2021
Effective Date: August 04, 2021

Sponsor

Name: Reynard Health Supplies (Aus) Pty Ltd

Manufacturer

Name: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San ve Tic AS
Country: Turkey
Address: Akcaburgaz Mah Muhsin Yazicioglu Cad No 45/5, Esenyurt, Istanbul

Intended purpose

This gel is used in endoscopy, colonoscopy, gynaecological examinations, rectal, endoscopic, catheter operations, and also used for vaginal lubrication applications.

About this record

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 Reynard Health Supplies (Aus) Pty Ltd, manufactured by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San ve Tic AS in Turkey. The device registration started on August 04, 2021.

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.