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    10137099C00 Newport EC Certificate (Exp 28-Aug-2022)

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    Rareș Andrei Onel
    This document is an EC certificate issued by DEKRA Certification B.V. to Newport Medical Instruments, Inc. for medical devices intended for ventilation of neonatal, pediatric, and adult patients. The certificate includes information on the manufacturer, products covered (e360 and HT70 ventilators and accessories), and validity until August 2022.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    10137099C00 Newport EC Certificate (Exp 28-Aug-2022)

    Uploaded by

    Rareș Andrei Onel
    127 views2 pages
    This document is an EC certificate issued by DEKRA Certification B.V. to Newport Medical Instruments, Inc. for medical devices intended for ventilation of neonatal, pediatric, and adult patients. The certificate includes information on the manufacturer, products covered (e360 and HT70 ventilators and accessories), and validity until August 2022.

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    This document is an EC certificate issued by DEKRA Certification B.V. to Newport Medical Instruments, Inc. for medical devices intended for ventilation of neonatal, pediatric, and adult patients. The certificate includes information on the manufacturer, products covered (e360 and HT70 ventilators and accessories), and validity until August 2022.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    127 views2 pages

    10137099C00 Newport EC Certificate (Exp 28-Aug-2022)

    Uploaded by

    Rareș Andrei Onel
    This document is an EC certificate issued by DEKRA Certification B.V. to Newport Medical Instruments, Inc. for medical devices intended for ventilation of neonatal, pediatric, and adult patients. The certificate includes information on the manufacturer, products covered (e360 and HT70 ventilators and accessories), and validity until August 2022.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    EC CERTIFICATE

    Number: 2112819CE01

    Full Quality Assurance System


    Directive 93/42/EEC on Medical devices, Annex II excluding (4)
    (Devices in Class IIa, IIb or III)

    Manufacturer:
    Newport Medical Instruments, Inc.
    1620 Sunflower Avenue
    Costa Mesa, CA 92626
    USA
    For the product category(ies)
    Medical Devices Intended for Ventilation of Neonatal, Pediatric and Adult Patients
    DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany
    the CE Marking of Conformity on the products concerned conforming to the required Technical
    Documentation and meeting the provisions of the EC-Directive which apply to them:

    0344
    Documents that form the basis of this certificate:
    Certification Notice 2112819CN, initially dated February 1, 2008
    Addendum, initially dated February 1, 2008
    DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische
    Hulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medical
    devices, including all subsequent amendments. The manufacturer has implemented a quality assurance system for
    design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of
    Annex II of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance. For placing on the
    market of Class III devices an additional EC design examination certificate according to Annex II (4) is mandatory.
    The necessary information related to the quality management system of the manufacturer, including facilities and the
    reference to the relevant documentation of the products concerned and the assessments performed are stated in the
    Certification Notice, which forms an integrative part of this certificate.

    This certificate is valid until: August 28, 2022


    Issued for the first time: February 1, 2008
    Revised: August 4, 2017
    Reissued: August 28, 2017
    DEKRA Certification B.V.

    2
    drs. G.J. Zoetbrood
    e
    ing. A.A.M. Laan
    Managing Director Certification Manager
    © Integral publication of this certificate and adjoining reports is allowed

    DEKRA Certification B.V. is Notified Body with ID no 0344

    DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
    T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396
    ADDENDUM
    Belonging to certificate: 2112819CE01 1/1

    CE MARKING OF CONFORMITY
    MEDICAL DEVICES

    Medical Devices Intended for Ventilation of Neonatal, Pediatric and Adult Patients

    Issued to:

    Newport Medical Instruments, Inc.


    1620 Sunflower Avenue
    Costa Mesa, CA 92626
    USA

    This certificate covers the following product(s):

     e360 Ventilator (Class IIb)


     HT70 Ventilator (Class IIb)
     HT70 Ventilator Accessories (Class IIa/IIb)

    Initial date: February 1, 2008


    Revision date: August 4, 2017

    DEKRA Certification B.V.

    2
    drs. G.J. Zoetbrood
    e
    ing. A.A.M. Laan
    Managing Director Certification Manager
    © Integral publication of this certificate and adjoining reports is allowed

    DEKRA Certification B.V. is Notified Body with ID no 0344

    DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
    T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

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