Product Regulatory Information

Manufacturer Information

VolparaDensity, VolparaEnterprise DDP, VolparaEnterprise and VolparaLive! are manufactured by Volpara Health Technologies Limited (VHT), of which Volpara Solutions Limited is a wholly owned subsidiary.

Reg VHT Reg VS Europe

 

Australian TGA Sponsor

Volpara Health Technologies Limited

Level 7, 44 Victoria Street
Wellington Central
Wellington 6011
New Zealand

Emergo Europe B.V.

Prinsessegracht 20
2514 AP The Hague
The Netherlands

AA-Med Pty Ltd

Brandwood CKC
Level 8, 1 Chandos Street
St Leonards NSW 2065
Australia

Risk Identification and Mitigation

In order to meet quality requirements, our risk management procedures have been developed to conform to EN ISO 14971:2012 (including Annex ZA) and ISO 27001:2013. The instructions for use and caveats contained within are traceable to the residual risks identified in those procedures.

External Certification

Volpara Health Technologies Limited’s quality management system has been certified as conforming to the requirements of ISO 13485:2016, Australia – Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure; Canada – Medical Devices Regulations – Part 1 – SOR 98/282; Japan – MHLW Ministerial Ordinance 169, Article 4 to Article 68, PMD Act; USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D by BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA. The Volpara Health Technologies Limited quality assurance system also meets the requirements of 93/42/EEC, Annex II excluding section 4 as assessed by BSI Group The Netherlands B.V. (Notified Body 2797), Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands. 

Current global regulatory clearances for Volpara Solutions products

 

US

Canada

EU

Australia

New Zealand

Agency

Food and Drug Administration (FDA)

Health Canada (HC)

Dutch Health and Youth Care Inspectorate

Therapeutic Goods Agency (TGA)

Medsafe

Register

Establishment & Device Listing database

Medical Devices Active Licence Listing (MDALL)

Dutch Health and Youth Care Inspectorate via Notified Body

Australian Register of Therapeutic Goods (ARTG)

Web Assisted Notification of Devices (WAND)1

Listed entity

VHT Limited

VHT Limited

VHT Limited

VHT Limited

VHT Limited

VolparaDensity

Class II

Class II

Class Im

Class Im

Class Im

Reference number

892.2050

88416

N/A

277936

160921-WAND-6MR5MS

VolparaEnterprise DDP

Class II

Class II

Class Im

Class Im

Class Im

Reference number

892.2050

88416

N/A

277936

160921-WAND-6MR5MS

VolparaEnterprise

Class I

Not a medical device

Not a medical device

Not a medical device

Not a medical device

Reference number

880.6310

N/A

N/A

N/A

N/A

VolparaLive! 

Class I Class I Class I Class I Class I

Reference number

892.1940 N/A N/A N/A N/A

Note: Volpara Solutions Limited products may be available for sale in other regulatory jurisdictions. Please contact your Volpara Solutions representative for more information.

Reg CE mark

2797 

1. Beyond the need to register devices and report adverse events, there are no locally enforced regulatory requirements in New Zealand at this time.