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Intravenous fluid container, single use - ARTG 368570

Access comprehensive regulatory information for Intravenous fluid container, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 368570 and sponsored by AddedPharma - Australia/NZ, manufactured by Hegewald Medizinprodukte GmbH in Germany. The device registration started on June 08, 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.

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TGA ARTG Official Data
Class Is
ARTG 368570
Class Is
Intravenous fluid container, single use
ARTG ID: 368570
Good Name: AddedPharma - Australia/NZ - Intravenous fluid container, single use
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Intended Purpose

These EVA Bags are sterile single-use consumables that have multiple uses; (1) they can be used as a resevoir to fill up and prepare syringes, bags, and vials, or (2) they can be used as a container of medication such as TPNs or antibiotics which can then be administered via gravity infusion. Please note that the EVA bags do not include any direct connection to the patient.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
368570
Start Date
June 08, 2021
Effective Date
June 08, 2021
Manufacturer
Country
Germany
Address
Gutsweg 1, Lichtenberg, Erzgebirge, 09638