Australia TGA ARTG record

Medicine administration kit, oral

Australia TGA ARTG Registered Device · Bayer Australia Ltd · Bayer AG · Class I · Started May 15, 2012

Good Name: Bayer Australia Ltd - Medicine administration kit, oral

Device classification

Risk Class: Class I
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: May 15, 2012
Effective Date: May 15, 2012

Sponsor

Name: Bayer Australia Ltd

Manufacturer

Name: Bayer AG
Country: Germany
Address: Mullerstrasse 178, Berlin, 13353

Intended purpose

To provide the patient an oral contraceptive tablet dispenser and YAZ Flex tablets to support intake of YAZ Flex tablets daily. The kit contains one tablet dispenser and one YAZ Flex 30 tablet dispenser pack. The oral contraceptive tablet dispenser is used to dispense solid dosage forms. The dispenser supports the user to take oral contraceptives on a regular basis at a defined time (reference time). The contraceptive tablets will be delivered in a dedicated cartridge (primary packaging containing the drug product) which fits into the dispenser. The user exchanges empty cartridges with new refilled cartridges when needed. The mechanically operated dispenser with a battery driven display enables the user to check the status of the contraceptive dosage regimen. Subsequently, the dispenser supports the user to take and track the use of YAZ Flex as intended by the market authorisation. For this purpose the dispenser has a visual and audible reminder (buzzer, alarm). The ultimate goal is to improve compliance by adhering to the dosage regimen. The Medical Device is designed as a refill concept, i.e. multiple use. The user has to exchange empty cartridges with new filled tablet cartridges.

About this record

Access comprehensive regulatory information for Medicine administration kit, oral in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Bayer Australia Ltd, manufactured by Bayer AG in Germany. The device registration started on May 15, 2012.

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.