Australia TGA ARTG record

Urinary-incontinence vaginal insert, reusable

Australia TGA ARTG Registered Device · PFLEX Pty Ltd T/a Rogers Family Trust · Invent Medic Sweden AB · Class IIb · Started October 24, 2023

Good Name: PFLEX Pty Ltd T/a Rogers Family Trust - Urinary-incontinence vaginal insert, reusable

Device classification

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

Registration information

Start Date: October 24, 2023
Effective Date: October 24, 2023

Sponsor

Name: PFLEX Pty Ltd T/a Rogers Family Trust

Manufacturer

Name: Invent Medic Sweden AB
Country: Sweden
Address: Nytankargatan 4, Lund, 223 63

Intended purpose

INVASIVE NON-ACTIVE MEDICAL DEVICE INTENDED TO TEMPORARILY REDUCE STRESS INDUCED URINE LEAKAGE IN WOMEN

About this record

Access comprehensive regulatory information for Urinary-incontinence vaginal insert, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by PFLEX Pty Ltd T/a Rogers Family Trust, manufactured by Invent Medic Sweden AB in Sweden. The device registration started on October 24, 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.