Ear/nose/throat treatment unit

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Stark Medical
Class:
Class IIa
Authorization status:
Included
Authorization number:
339702

Public Summary

Summary for ARTG Entry:

339702

Stark Medical - Ear/nose/throat treatment unit

ARTG entry for

Medical Device Included Class IIa

Sponsor

Stark Medical

Postal Address

5 / 77 Million Road, Cremorne Point, NSW, 2090

Australia

ARTG Start Date

17/07/2020

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

Atmos Medizintechnik GmbH & Co

Ludwig-Kegel-strasse 16

Lenzkirch, Germany, 79853

Germany

Products

1 . Ear/nose/throat treatment unit

Product Type

Medical device system

Effective Date

17/07/2020

GMDN

11585 Ear/nose/throat treatment unit

Intended Purpose

Ear/nose/throat treatment unit

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 22.07.2020 at 08:44:30 AEST

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

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