Caring for Health

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  • TECHNOLOGY FROM ROODINSEAT

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    品質認證

    Manufacturer declares that:

    • The above products comply with the following performance standards,
      1. EN 60601-1
      2. EN 60601-1-2
    • All devices in scope meet the essential requirements set out in Annex
    • The manufacturing site for the above products complies with EN ISO 9001:2008/EN ISO13485:2012 Quality Management System Requirements for Medical Devices.