Product Regulatory Information

Manufacturer Information

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

Lunit International Limited EU Authorized Representative Australian TGA Sponsor United Kingdom Responsible Person (UKRP) Malaysia Legal Representative
Level 4
1 Victoria Street Wellington 6011 New Zealand		 MedEnvoy Global B.V.
Prinses Margrietplantsoen 33 – Suite 123 2595 AM The Hague The Netherlands		 Emergo Australia
Level 20 Tower II, Darling Park 201 Sussex Street Sydney NSW 2000 Australia		 MedEnvoy UK Limited
167-169 Great Portland Street, First Floor London, W1W 5PF United Kingdom		 Taevas Life Sciences Sdn Bhd. (1407342-P) Suite 163E, Level 16
Gurney Paragon Office Tower, Jalan Kelawei, 10250 George Town Pulau Pinang, Malaysia medcast.

malaysia@freyrsolutions.com
MDA Reg. No. GB7501225-208554

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: customersupport@lunit.io.
  • To request paper copies, please email a request to: customersupport@lunit.io. 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 EN ISO 14971:2019+ A11:2021 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’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 Lunit International 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 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
Volpara Scorecard Class II Class II Class Im Class Im Class Im
Reference number 892.2050 88416 663778 277936 160921-WAND-6MR5MS
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 Live Class I Not a medical device Not available Not available Class I
Reference number 892.1940 N/A N/A N/A N/A
Note: Lunit International Limited products may be available for sale in other regulatory jurisdictions. Please contact your Lunit representative for more information.