NEURO-MEP-MICRO

Main information

  • Trade name:
  • NEURO-MEP-MICRO - Electromyograph
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • NEURO-MEP-MICRO - Electromyograph
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219362
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219362

Atris Pty Ltd - NEURO-MEP-MICRO - Electromyograph

ARTG entry for

Medical Device Included Class IIb

Sponsor

Atris Pty Ltd

Postal Address

19 Duchess Avenue,RODD POINT, NSW, 2046

Australia

ARTG Start Date

17/01/2014

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Neurosoft Ltd

Voronin str 5

Ivanovo, , 153032

Russian Federation

Products

1. NEURO-MEP-MICRO - Electromyograph

Product Type

Medical device system

Effective date

17/01/2014

GMDN

11474 Electromyograph

Intended purpose

The 2-channel digital neurophysiologycal system for EMG and EP with a built-in miniature dedicated

keyboard "Neuro-MEP-Micro" intended for the study of 1-2 channel electrical activity of muscles and also

somatosensory, visual, auditory evoked potentials (EP) and biopotentials during magnetic stimulation by

biopotentials registration and input into personal computer (PC), its measurement, calculation and analysis

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 07:49:44 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

15-11-2018

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27-8-2018

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9-7-2018

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27-6-2018

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16-5-2018

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16-5-2018

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