Certificate of Registration

Transcription

1 Certificate of Registration This is to certify that the quality management system of AGFA HEALTHCARE N.V. including companies according to appendix Main site: Septestraat 27, 2640 Mortsel, Belgium Additional sites according to appendix has been assessed and registered by Intertek as conforming to the requirements of ISO 9001:2015 ISO 13485:2016 The quality management system is applicable to Provision of medical imaging and healthcare IT Certificate Number: Initial Certification Date: Certificate Issue Date: Certificate Expiry Date: (9001), (13485) 3 August May May 2020 Thomas Andersson, CEO Intertek Certification AB P.O. Box 1103, SE Kista, Sweden In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification Agreement. This certificate s validity is subject to the organization maintaining their system in accordance with Intertek s requirements for systems certification. Validity may be confirmed via at certificate.validation@intertek.com or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to whom it must be returned upon request.

2 1 (4) This appendix identifies the locations by the management system of AGFA HEALTHCARE N.V. IT Agfa HealthCare N.V., Moutstraat 100, 9000 Ghent, Belgium Agfa HealthCare Ges.m.b.H, Diefenbachgasse 35, 1150 Vienna, Austria Agfa HealthCare France, Avenue de l église romane 4, Artigues Près Bordeaux, France Agfa HealthCare GmbH, Konrad-Zuse-Platz 1-3, Bonn, Germany Agfa HealthCare GmbH, Monaiser Str. 11, Trier, Germany Agfa HealthCare GmbH, Gartenstrasse 89, Rottenburg, Germany Agfa HealthCare Inc., 375 Hagey Boulevard, Waterloo, Ontario N2L 6R5, Canada Agfa HealthCare (Shanghai) Co., Ltd., 15F No.388 West Nanjing Road, CIRO s Plaza, Shanghai, People's Republic of China Agfa HealthCare Corporation, 150 Royall Street, Canton, Massachusetts 02021, USA Development of healthcare IT Development of healthcare IT Development of healthcare IT Development of healthcare IT Development of healthcare IT Development of healthcare IT Development of healthcare IT Development of healthcare IT Development of healthcare IT

3 2 (4) Imaging Agfa-Gevaert HealthCare GmbH, Tegernseer Landstr. 161, München, Germany Agfa-Gevaert HealthCare GmbH, Bürgermeister- Götz-Str. 10, Schrobenhausen, Germany Agfa-Gevaert HealthCare GmbH, Max-Planck- Str. 1, Peißenberg, Germany Agfa-Gevaert HealthCare GmbH, Dr. Kisselmann Str. 1, Peiting, Germany Development of medical imaging Manufacturing of medical imaging Manufacturing of medical imaging Manufacturing of medical imaging Sales and Service Units Australia Agfa HealthCare Australia Pty Ltd, 15 Dalmore Drive, Scoresby VIC 3179, Australia Belgium, Luxembourg Agfa HealthCare N.V., Septestraat 27, 2640, Mortsel, Belgium Agfa HealthCare Luxembourg S.A., Route de Longwy 74, L-8080 Helfenterbruck, Luxembourg Canada Agfa HealthCare Inc., Falbourne St., Mississauga, Ontario L5R 3V8, Canada France Agfa HealthCare France, Avenue de l'église romane 4, Artigues Près Bordeaux, France Agfa HealthCare France, Boulevard Paul Vaillant- Couturier 45-47, Ivry-sur-Seine Cedex, France

4 3 (4) Germany, Austria, Switzerland Agfa HealthCare GmbH, Konrad-Zuse-Platz 1-3, Bonn, Germany Agfa HealthCare Ges.m.b.H., Diefenbachgasse 35, 1150 Vienna, Austria Agfa HealthCare AG, Stettbachstrasse 7, CH-8600 Dübendorf, Switzerland Greece Agfa HealthCare A.E.B.E, Stylianou Gonata 16, Peristeri, Greece Spain, Italy, Portugal Agfa HealthCare Spain, S.A.U., C/. Gaspar Fàbregas i Roses, 81-3ª plta., 8950 Esplugues de Llobregat (Barcelona), Spain Agfa HealthCare Equipments Portugal, Lda., Praceta António Gedeâo, nº 1 B Paiôes, Rio de Mouro, Portugal Agfa-Gevaert SpA, Via Massimo Gorki 69, Cinisello Balsamo, Milano, Italy Sweden, Denmark, Norway, Finland Agfa HealthCare Sweden AB, Arne Beurlings Torg 9A, SE Kista, Sweden Agfa HealthCare Denmark A/S, Birkerød Kongevej 150B, 3460 Birkerød, Denmark Agfa HealthCare Finland Oy Ab, Keilaranta 16, FI Espoo, Finland Agfa HealthCare Norway AS, Sandakerveien 121, NO-0484 Oslo, Norway

5 4 (4) The Netherlands Agfa-Gevaert B.V., Polakweg 10-11, 2288 Rijswijk, The Netherlands United Kingdom, Ireland Agfa HealthCare UK Limited, Vantage London, Great West Road, Brentford TW8 9AX, United Kingdom USA Agfa HealthCare Corporation, 10 South Academy Street, Greenville, South Carolina 29601, USA Agfa HealthCare Corporation, 580 Gotham Parkway, Carlstadt, NJ 07072, USA Certificate Number: (9001), (13485) Initial Certification Date: 3 August 1990 Certificate Issue Date: 17 May 2017 Certificate Expiry Date: 31 May 2020 Thomas Andersson, CEO Intertek Certification AB P.O. Box 1103, SE Kista, Sweden In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification Agreement. This certificate s validity is subject to the organization maintaining their system in accordance with Intertek s requirements for systems certification. Validity may be confirmed via at certificate.validation@intertek.com or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to whom it must be returned upon request.