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  • Certificate No. 60149222

    • Certificate Number
      DD 60149222
    • Certificate Holder
      AT&M Biomaterials Co., Ltd.
      No. 12 YongCheng Bei Road
      Zhongguancun Yongfeng
      Industry Base
      Haidian District
      100094 Beijing
      China (Mainland)
    • Scope

      Medical Devices
      (See Attachment for Products included)
      Replaces Approval, Registration No.: HD 60145754 0001
      - Alloys for Dental Amalgam
      - Dental Filling Resins
      - Dental Bonding Agent
      - Glass Ionomer Dental Cement
      - Dental Pit/Fissure Sealant
      - Etchant Gels

    • 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.