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Certificate No. 60136153

  • Certificate Number
    DD 60136153
  • Certificate Holder
    2F&3F, East Section, Building 12
    Power valley pioneer park
    No. 369 Huiyang street
    071051 Hebei
    China (Mainland)
  • Scope

    Medical Oxygen Concentrators
    Replaces Approval, Registration No.: DD 60108301 0001

  • 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.