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Certificado nº 60143837

  • Número de Certificado
    SX 60143837
  • Certificado Titular
    Gebr. Brasseler GmbH & Co. KG

    Trophagener Weg 25
    32657 Lemgo
    Alemania
  • Alcance de la Certificación

    Design and development, manufacture and distribution
    of non-active medical devices
    (see attachment for products included)
    Products included:
    - Rotary and oscillating instruments for dentistry
    dermatology, surgery and ophthalmology
    - Rotary instruments and saw blades for orthopedics,
    - Posts, screws and prefabricated elements as well as
    auxiliary parts for the restoration of teeth
    - Instruments for podiatry
    - Agents for the cleaning and disinfection of
    medical devices
    - Pins and screws for use in orthopedics
    Products included:
    - Rotary endodontic instruments
    drying the root canal
    - Filling material for root canals and paper points for
    - Dental hand pieces and contra-angles
    - Sterilization containers and bur blocks
    - Manual instruments and tools for use in dentistry
    - Elastomeric elements

  • Estándares cumplidos
    EN ISO 13485:2016
  • Tipo de Certificado
    QMS

    Quality Management System
    EN ISO13485 quality management standard for medical devices and related services

    The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

    Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

    The customer's quality management system is subject to regular monitoring.

    Certified customers may use the test mark in their communication.

    Further information on this service can be found here.