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inomed C2 xplore - Patient monitor, nerve - ARTG 380231

Access comprehensive regulatory information for inomed C2 xplore - Patient monitor, nerve in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 380231 and sponsored by Neuroclast Pty Ltd, manufactured by inomed Medizintechnik GmbH in Germany. The device registration started on December 06, 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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Class IIa
ARTG 380231
Class IIa
inomed C2 xplore - Patient monitor, nerve
ARTG ID: 380231
Good Name: Neuroclast Pty Ltd - inomed C2 xplore - Patient monitor, nerve
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Intended Purpose

Intended for identifying cranial and peripheral nervous tissue with motor or sensor function as well as monitoring the functional integrity of these structures during surgery. Indicated for use in procedures such as; intracranial, extracranial, intratemporal and extratemporal procedures as well as neck dissections, thoracic surgeries, and upper and lower extremities. Suitable for use in spinal procedures such as; degenerative treatments, pedicle screw procedures, fusion cages, rhizomotomy, orthopaedic surgery, open and percutaneous lumbar and cervical surgical procedures, and thoracic surgical procedures. Not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
380231
Start Date
December 06, 2021
Effective Date
December 06, 2021
Manufacturer
Country
Germany
Address
IM Hausgrun 29, Emmendingen, 79312