Calliper, general-purpose

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

Buy It Now

Available from:
Medi-Rent Pty Ltd
Class:
Class Im
Authorization status:
Included
Authorization number:
290296

Read the complete document

Public Summary

Summary for ARTG Entry:

290296

Medi-Rent Pty Ltd - Calliper, general-purpose

ARTG entry for

Medical Device Included Class Im

Sponsor

Medi-Rent Pty Ltd

Postal Address

Unit 3/ 61 Beauchamp Road,MATRAVILLE, NSW, 2036

Australia

ARTG Start Date

16/06/2017

Product category

Medical Device Class Im

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

Pero-System Messgerate GmbH

Am Tescher Busch 9

Wuppertal, , 42327

Germany

Products

1. Calliper, general-purpose

Product Type

Single Device Product

Effective date

16/06/2017

GMDN

32262 Calliper, general-purpose

Intended purpose

The Perometer captures two perpendicular diameters of a limb placed in the frame. A

large number of light barriers is forming the virtual jaws of a caliper. The diameters are

determined by counting the number of obscured LEDs. The positions of the diameters

are determined by counting the non obscured LEDs. While the frame is moved manually

over the length of the limb, this procedure is repeated each 4.7 millimeter. The computer

constructs an image of the limb and calculates volumes and circumferences.

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 03.11.2017 at 04:37:28 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

Search alerts related to this product

Share this information