General laboratory assay container, sterile

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

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Available from:
Gytech Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322741

Public Summary

Summary for ARTG Entry:

322741

Gytech Pty Ltd - General laboratory assay container, sterile

ARTG entry for

Medical Device Included Class IIa

Sponsor

Gytech Pty Ltd

Postal Address

PO Box 8631,Armadale, VIC, 3143

Australia

ARTG Start Date

5/09/2019

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

IM Services BV

Herfterlaan 51

RD, Zwolle, 8026

Netherlands

Products

1. General laboratory assay container, sterile

Product Type

Single Device Product

Effective date

5/09/2019

GMDN

46238 General laboratory assay container, sterile

Intended purpose

Sterile containers, tubes, pipettes and dishes used during assisted reproductive technology.

Specific Conditions

© 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 02.11.2019 at 05:03:08 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

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