DNVBUSINESS ASSURANCE MANAGEMENT

DNV BUSINESS ASSURANCE
MANAGEMENT SYSTEM CERTIFICATE
Certificate No. 175379-2015-AQ-NOR-NA
This is to certify that the Management System of:
Elos AB
Nya Stadens Torg 10, 531 31 Lidköping, Sweden
with sites as per attachment
has been found to conform to the standard:
ISO 13485:2003/NS-EN ISO 13485:2012
This Certificate is valid for the following product or service ranges:
Development, Design, Manufacturing, Packaging and Distribution of general
non-active, non-implantable medical devices, non-active implants, non-active
dental devices and accessories, general active medical devices, general active
implantable medical devices, and components to In Vitro Diagnostic
Medical Devices (IVD).
Initial Certification date:
Place and date:
27 December 2010
Høvik, 10 April 2015
This Certificate is valid until:
DET NORSKE VERITAS
CERTIFICATION AS, NORWAY
for the Accredited Unit:
12 April 2018
The audit has been performed under the
supervision of
Bjørg Synnøve Nesgård
Lead Auditor
MSYS 002
Morten Egeberg
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
This Certificate has been digitally signed. See www.dnv.com/digitalsignatures for more info
HEAD OFFICE. Det Norske Veritas AS, Veritasveien 1, 1322 Hovik, Norway. Tel: +47 67 57 99 00 Fax: +47 67 57 99 11 - www.dnv.com
DNV BUSINESS ASSURANCE
APPENDIX TO CERTIFICATE
This Appendix refers to Certificate No. 175379-2015-AQ-NOR-NA
Elos AB
locations included in the certification are as follows:
Site Name
Site Address
Certificate scope
Elos Medtech Pinol A/S
Engvej 33, 3330
Gørløse, Denmark
Development, Design, Manufacturing, Packaging and Distribution of
general non-active, non-implantable medical devices, non-active implants,
non-active dental devices and accessories, general active medical devices,
and components to In Vitro Diagnostic Medical Devices (IVD).
Elos Medtech
Timmersdala AB
Bäckedalsvägen 5, 540
16 Timmersdala,
Sweden
Development, Design, Manufacturing, Packaging and Distribution of
general non-active, non-implantable medical devices, non-active implants,
non-active dental devices and accessories, general active medical devices
general active implantable medical devices, and components to In Vitro
Diagnostic Medical Devices (IVD).
Elos Medtech Microplast
AB
Manufacturing and Packaging of general non-active, non-implantable
Hästhagsgatan 2, 532 22 medical devices, non-active implants, non-active dental devices and
Skara, Sweden
accessories, and components to In Vitro Diagnostic Medical Devices
(IVD).
Elos Medtech Tianjin Co.
Ltd.
D5-3, Rongcheng
Sanzhilu, Xeda
International Industrial
City, Xiqing Economic
Development Area,
Tianjin, China
Manufacturing and Packaging of general non-active, non-implantable
medical devices, non-active implants, non-active dental devices and
accessories, and components to In Vitro Diagnostic Medical Devices
(IVD).
Initial Certification date:
Place and date:
27 December 2010
Høvik, 10 April 2015
This Certificate is valid until:
DET NORSKE VERITAS
CERTIFICATION AS, NORWAY
for the Accredited Unit:
12 April 2018
The audit has been performed under the
supervision of
Bjørg Synnøve Nesgård
Lead Auditor
MSYS 002
Morten Egeberg
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
This Certificate has been digitally signed. See www.dnv.com/digitalsignatures for more info
HEAD OFFICE. Det Norske Veritas AS, Veritasveien 1, 1322 Hovik, Norway. Tel: +47 67 57 99 00 Fax: +47 67 57 99 11 - www.dnv.com