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Product regulatory information

Manufacturer Information

Volpara Scorecard, Volpara Analytics and Volpara Live are manufactured by Volpara Health Technologies Limited (VHT), of which Volpara Health, Inc. is a wholly owned subsidiary.

Volpara Health Technologies Limited

Level 14
40 Mercer Street
Wellington Central
Wellington 6011
New Zealand

EU Authorized Representative

Emergo Europe B.V.
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Australian TGA Sponsor

AA-Med Pty Ltd,
Pharmalex Pty Ltd,
Suite 10.04
1 Chandos Street
St Leonards
NSW 2065

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 4 – Product Quality Assurance Procedure; Canada – Medical Devices Regulations – Part 1 – SOR 98/282; 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 Health 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
Volpara Scorecard Class II Class II Class Im Class Im Class Im
Reference number 892.2050 88416 N/A 277936 160921-WAND-6MR5MS
Volpara Analytics 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
Volpara Live Class I Class I Class I Class I Class I
Reference number 892.1940 N/A N/A N/A N/A

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

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