End-cut

Main information

  • Trade name:
  • End-cut biopsy gun, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • End-cut biopsy gun, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216710
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216710

Medlogical Pty Ltd - End-cut biopsy gun, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medlogical Pty Ltd

Postal Address

70 Brighton Avenue,TORONTO, NSW, 2283

Australia

ARTG Start Date

30/10/2013

Product category

Medical Device Class IIa

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

Somatex Medical Technologies GmbH

Rheinstrasse 7D

, Teltow, 14513

Germany

Products

1. End-cut biopsy gun, single-use

Product Type

Single Device Product

Effective date

30/10/2013

GMDN

22726 End-cut biopsy gun, single-use

Intended purpose

BIopsy gun to obtain tissue sample for histopathological diagnosis

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 04:28:58 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

17-11-2018

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