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  • Certificate No. 60151346

    • Certificate Number
      DD 60151346
    • Certificate Holder
      Foshan COXO Medical Instrument
      Co., Ltd.
      BLDG 4, District A
      Guangdong New Light Source
      Industrial Base, South of Luocun Av
      Nanhai District
      528226 Guangdong
      China (Mainland)
    • Scope

      Active dental devices
      (see attachment for products included)
      Replaces EC Certificate No. DD 60150762 0001
      - Root Apex Locators
      - Endo Motors
      - Pulp Testers
      - High-speed Air Turbine Handpieces
      - Straight Handpieces
      - Geared Angle Handpieces
      - Air Motors
      - Dental Implantation Systems
      - Dental Electrical Motors
      - Endodontic Obturation Systems

    • Fulfilled Standards
      Richtlinie 93/42/EWG
    • Certificate Type
      QMS Produktion, Anhang V MDD

      The Notified Body authorizes the quality management System established and applied by the Company mentioned in the certificate. The requirements of Annex V, Article 3 of the EC directive 93/42/EEC, referred to as the Medical Device Directive (MDD), have been met. This approval is subject to periodic surveillance, defined in Annex V, Article 4 of the aforementioned EC-Directive, and can be used by the Company with the manufacturer's declaration of conformity.