Collection

Main information

  • Trade name:
  • Collection syringe adaptor, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Collection syringe adaptor, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217643
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217643

C R Kennedy & Co Pty Ltd - Collection syringe adaptor, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

C R Kennedy & Co Pty Ltd

Postal Address

PO Box 82,PORT MELBOURNE, VIC, 3207

Australia

ARTG Start Date

22/11/2013

Product category

Medical Device Class 1

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

AS Medizintechnik GmbH

Sattlerstrasse 15

Tuttlingen, , 78532

Germany

Products

1. Collection syringe adaptor, reusable

Product Type

Single Device Product

Effective date

22/11/2013

GMDN

56638 Collection syringe adaptor, reusable

Intended purpose

A small device designed be placed over the top of a syringe to encase the tip of the syringe as means to

modify the shape and the size of the syringe tip.

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 23.11.2017 at 03:55:28 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

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 This report describes the framework of collection, management and transmission of food safety data in the Federal Republic of Germany. To adjust optimally the data governance processes to the requirements defined by the EFSA, measures had been agreed upon in order to improve the specified situation. Subsequent methodological system enhancements related to data quality are given as well as structural adjustments and the development and implementation of suppo...

Europe - EFSA - European Food Safety Authority Publications

5-10-2017

Collection of scientific experience for medicinal cannabis pilot programme

Collection of scientific experience for medicinal cannabis pilot programme

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Danish Medicines Agency

14-6-2017

To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance

To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance

The European Medicines Agency (EMA) will improve and update EudraVigilance, the database for collection and administration of adverse reaction reports for pharmaceutical companies and authorities. It is important that marketing authorisation holders and representatives become familiar with technical functionalities in time. New EudraVigilance will be launched on 22 November 2017. 

IMA - Icelandic Medicines Agency

5-9-2018

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulato

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulato

Access is a matter of public health. Facilitating dialogue between device makers and payors during planning phase of clinical trials can expedite patient access to safe, effective devices; esp. through collection of clinical evidence that informs regulatory and coverage decisions

FDA - U.S. Food and Drug Administration