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Rapamune Oral Solution System - Medicine administration kit, oral

Access comprehensive regulatory information for Rapamune Oral Solution System - Medicine administration kit, oral in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Pfizer Australia Pty Ltd, manufactured by Patheon Inc in Canada. The device registration started on October 14, 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.

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TGA ARTG Official Data
Class Im
Class Im
Rapamune Oral Solution System - Medicine administration kit, oral
Australia TGA ARTG Registered Device
Good Name: Pfizer Australia Pty Ltd - Rapamune Oral Solution System - Medicine administration kit, oral
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Intended Purpose

A medicine pack that contains devices needed to administer a dose of medication through oral intake. The pack contains the medication in a bottle, dedicated syringes that allow for the measurement of a small, precise volume of medication, a syringe adaptor that fits into the neck of the bottle and a carrying case. This is a single-patient, reusable system that is reused by the patient until the medication is consumed.

Device Classification
Risk Class
Class Im
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
October 14, 2019
Effective Date
October 14, 2019
Manufacturer
Country
Canada
Address
Whitby Operations 111 Consumers Drive, Whitby, Ontario, Canada, L1N 5Z5