Product Regulatory Information

Manufacturer Information

VolparaDensity, Volpara Density Map, VolparaDoseRT, and VolparaDoseSR are manufactured by Volpara Health Technologies Limited (VHT), of which Volpara Solutions Limited and Volpara Solutions Europe Limited are wholly owned subsidiaries.

Reg VHT Reg VS Europe

 

Australian TGA Sponsor

Volpara Health Technologies Limited

Level 12
86 Victoria Street
Wellington 6011
New Zealand

Volpara Solutions Europe Limited

Warr and Co
Mynshull House
78 Churchgate
Stockport SK1 1YJ, UK

AA-Med Pty Ltd

Brandwood Biomedical Pty Limited
Suite 2, 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 ISO 14971:2012 and EN ISO 14971:2012 (including Annex ZA). The instructions for use and caveats in this documentation are traceable to the residual risks identified in those procedures.

External Certification

Volpara Health Technologies Limited’s quality system has been certified as conforming to the requirements of ISO 13485:2003, ISO 13485:2012, and Annex VII of 93/42EEC (Medical Device Directive) by BSI Healthcare (Notified Body 0086) Medical Devices Certification, BSI Healthcare, Kitemark Court, Davy Avenue, Milton Keynes, MK5 8PP, under their accreditations by UKAS and SCC.

Current global regulatory clearances for Volpara Solutions products

Jurisdiction

US

Canada

EU

Australia

New Zealand

Agency

Food and Drug Administration (FDA)

Health Canada (HC)

Medicines & Healthcare products Regulatory Agency (MHRA)

Therapeutic Goods Agency (TGA)

Medsafe

Register

Establishment & Device Listing database

Medical Devices Active Licence Listing (MDALL)

Public Access Database

Australian Register of Therapeutic Goods (ARTG)

Web Assisted Notification of Devices (WAND)1

Listed entity

VHT Limited

VHT Limited

Volpara Solutions Europe Limited2

VHT Limited

VHT Limited

VolparaDensity

Class II

Class II

Class Im

Class Im

Class Im

Reference number

892.2050

88416

CA012855

277936

160921-WAND-6MR5MS

VolparaDose

Class I

Not a medical device

Class Im

Not a medical device

Class Im

Reference number

892.1940

N/A

As above

N/A

160921-WAND-6MR5MS

VolparaServer

Not required to be registered

Not a medical device

Class Im (accessory)

Not a medical device

Class Im

Reference number

892.2020

N/A

As above

N/A

160921-WAND-6MR5MS

VolparaAnalytics

Not required to be registered

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

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

Reg CE mark0086

 

1. Beyond the need to register devices and report adverse events, there are no locally enforced regulatory requirements in New Zealand at this time.
2. Volpara Solutions Europe Limited is VHT’s EU Authorized Representative under the Medical Device Directives. At the time of publication, the details in MHRA’s public database are in the process of being updated. Please direct any inquiries to VHT Limited.