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Certificate No. 60134007

  • Certificate Number
    HD 60134007
  • Certificate Holder
    Vega Technologies Inc.
    11F-13., No. 100, Chang Chun Road
    Taipei 104
    China (Taiwan)
  • Scope

    Medical Devices:
    Products:
    - Continuous Positive Airway Pressures (CPAP)
    - Nebulizers
    - Digital Thermometers
    - Electric Suction Units
    - Heated Humidifiers
    Replaces Approval, Registration No.: HD 60134007 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.