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  • Certificate No. 60125635

    • Certificate Number
      HD 60125635
    • Certificate Holder
      "Astar ABR"
      Aleksander Jedrzejowski,
      Robert Dziendziel Spolka Jawna
      ul. Swit 33
      43-382 Bielsko-Biala
      Poland
    • Scope

      (see attachment for products included)
      Replaces Certificate, Registration No.: HD 60097823 0001
      Products included:
      - Electrotherapy devices
      - Light therapy devices
      - Laser therapy devices
      - Magnetic field therapy devices
      - Ultrasound therapy devices
      - Ultrasound therapy combined with electrotherapy devices
      - Vacuum therapy devices
      - Shock wave physical therapy devices

    • Fulfilled Standards
      Richtlinie 93/42/EWG
    • Certificate Type
      Vollst. QMS, Anhang II MDD

      EC declaration of conformity (Full quality assurance system)
      Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

      The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

      The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

      This approval can be used by the company in line with the declaration of conformity.