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CE-CERTIFICATION/QM

  • EC "design-dossier"certificate
    acc. to Appendix 2.4 Directive 90/385/EEC
  • EC certificate "Full Quality Assurance System"
    acc. to Appendix 2.3 Directive 90/385/EEC
  • Quality Management Systems EN ISO 13485:2012
    for "design and development, production,
    sale and distribution of devices and implants
    for the therapy with electromagnetic fields"

    Notified body:
    TÜV SÜD Product Service GmbH

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