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      • Pocket Dermoscopy Devices
      • Photo Dermoscopy Devices
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      Regulatory

      Medical Devices Regulation (MDR)
      All DermLite devices conform to the Medical Devices Regulation (EU) 2017/745 (MDR), and we are registered as a manufacturer with EUDAMED under SRN US-MF-000005170.

      Authorized Representative
      ECREP LIMITED
      SRN: IE-AR-000003995
      5 Fitzwilliam Square East
      Dublin, D02 R744
      Ireland
      Tel: +353 89 225 1951

       Certificates & Registrations

      • CE Certificate 2024-2025 (dated 1 March 2025)
      • EU MDR Certificate of Conformity (dated 20 June 2024)
      • UK Certificate of Conformity (dated 20 June 2024)
      • US FDA Establishment Registration & Device Listing
      • Declaration of Conformity MedDO (Switzerland, dated 20 June 2024)
      • Certificate to Foreign Government (dated September 2023)
      • ISO 13485:2016 Certificate (dated 30 Dec 2023)
      • DermLite Code of Conduct (dated 31 August 2023)

       

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