Product Regulatory Information

Manufacturer Information

Volpara Scorecard, Volpara Analytics, and Volpara Live are manufactured by Lunit International Limited.

Lunit International Limited

Level 4, Ricoh House
1 Victoria Street
Wellington 6011
New Zealand

EU Authorized Representative

MedEnvoy Global B.V.
Prinses Margrietplantsoen 33 – Suite 123
2595 AM The Hague
The Netherlands

Australian TGA Sponsor

AA-Med Pty Ltd,
Suite 22.02,
101 Miller Street,
North Sydney
NSW 2060
Australia

Accessing Instructions for Use

Volpara Scorecard user guides are available in PDF format at the links provided to customers during onboarding and subsequently through release information communicated via email. To view these online, you will need an internet browser with Adobe Acrobat Reader installed.

  • If you don’t currently have access, please email a request to: support@volparahealth.com.
  • To request paper copies, please email a request to: support@volparahealth.com.
  • Paper copies will be sent free of charge within seven days of receiving your request.
  • To find the Unique Device Identifier (UDI) and manufacturer details for Volpara Scorecard and Volpara Live, please refer to our Product labels page.

Risk Identification and Mitigation

In order to meet quality requirements, our risk management procedures have been developed to conform to BS EN ISO 14971:2019 and ISO 27001:2022. The instructions for use and caveats contained within are traceable to the residual risks identified in those procedures.

External Certification

Lunit International Limited 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 Netherland (*updated certificate pending).

Current Global Regulatory Clearances for Lunit International Limited 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 Lunit International Limited Lunit International Limited Lunit International Limited* Lunit International Limited Lunit International Limited
Tableau de bord Volpara Class II Class II Class Im Class Im Class Im
Reference number 892.2050 88416 663778 277936 160921-WAND-6MR5MS
Volpara Analytics Non-device MDDS Not a medical device Not a medical device Not a medical device Not a medical device
Reference number N/A N/A N/A N/A N/A
Volpara en direct Class I Not a medical device Not available Not available Class I
Reference number 892.1940 N/A N/A N/A N/A