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PainChek® is a medical device: ALWAYS FOLLOW THE DIRECTIONS FOR USE. Landmark US FDA De Novo Grant received for PainChek Adult

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    ASX Announcements

    2026

    2 September 2026 PCK – Resignation of Non-Executive Director PDF 25 May 2026 PCK – Lil Bianchi appointed Non-Executive Chair of PainChek PDF 4 March 2026 PCK – Notification of cessation of securities PDF

    2025

    8 October 2025 PCK – Application for quotation of securities PDF 30 September 2025 PCK – Corporate Governance Statement and Appendix 4G 2025 PDF 7 July 2025 PCK – Change in Directors’ Interest Notice x 5 PDF
    Archived asx announcements
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    PainChek® meets regulatory standards for use in Australia, New Zealand, Canada, Singapore, Malaysia, the United Kingdom, the European Union, and PainChek® Adult has been granted a De Novo classification by the US Food and Drug Administration (FDA) for its PainChek® Adult App. The FDA De Novo Grant number is DEN240073. The tool is included in the Australian Register of Therapeutic Goods (ARTG) under ARTG number 302794.

    PainChek® is a registered trade mark of PainChek in Australia, the United Kingdom, the European Union, and a trade mark in other jurisdictions.

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