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Eledyn EB 10 - Catheter, cardiac, balloon, pacing electrode

Access comprehensive regulatory information for Eledyn EB 10 - Catheter, cardiac, balloon, pacing electrode in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by B Braun Australia Pty Ltd, manufactured by B Braun Melsungen AG in Germany. The device registration started on January 17, 2024.

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 III
Class III
Eledyn EB 10 - Catheter, cardiac, balloon, pacing electrode
Australia TGA ARTG Registered Device
Good Name: B Braun Australia Pty Ltd - Eledyn EB 10 - Catheter, cardiac, balloon, pacing electrode
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Intended Purpose

Eledyn EB 10 is a bipolar balloon pacing catheter intended for temporary transvenous pacing or electrophysiological monitoring for patients with impaired impulse formation or conduction.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 17, 2024
Effective Date
January 17, 2024
Manufacturer
Country
Germany
Address
Carl-Braun-Str 1, Melsungen, 34212