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BSI ISO - 13485 - Zertifikat - Stryker - Medical - Portage - 2019

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63 views2 pages

BSI ISO - 13485 - Zertifikat - Stryker - Medical - Portage - 2019

Uploaded by

x1939101
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Certificate of Registration

QUALITY MANAGEMENT SYSTEM – ISO 13485:2016

This is to certify that: Stryker Medical


3800 E. Centre Avenue
Portage
Michigan
49002
USA

DUNS Number: 00-825-6356

Holds certificate No: MDSAP 640627

Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the
following criteria: ISO 13485:2016 and Australia - Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3
Part 1 (excluding Part 1.6) - Full Quality Assurance Procedure [if design controls are part of the certification]; Brasil - RDC
ANVISA n. 16/2013, RDC ANVISA n. 23/2012, RDC ANVISA n. 67/2009; Canada - Medical Devices Regulations - Part 1-
SOR 98/282; USA - 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D

Design and development, manufacture, distribution and service of medical/surgical beds, stretchers,
mattresses, building evacuation, pre and post hospital patient transport, transfer equipment, temperature
management devices, associated hospital furniture, and stand-alone software for medical use; including
installation.

For and on behalf of BSI:


Carlos Pitanga, Chief Operating Officer Assurance - Americas

Original Registration Date: 2016-03-23 Effective Date: 2018-10-05 Expiry date: 2021-10-16

Page: 1 of 2

This certificate remains the property of BSI and shall be returned immediately upon request.
To be read in conjunction with the scope above or the attached appendix.

Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.
Certificate No: MDSAP 640627

Location Registered Activities


Stryker Medical Design and development, manufacture, distribution and service
3800 E. Centre Avenue of medical/surgical beds, stretchers, mattresses, building
Portage evacuation, pre and post hospital patient transport, transfer
Michigan equipment, temperature management devices, associated
49002 hospital furniture, and stand-alone software for medical use;
USADUNS including installation.
Number: 07-847-0558
Stryker Medical Design and development, manufacture, distribution and service
6300 S. Sprinkle Rd. of medical/surgical beds, stretchers, mattresses, building
Portage evacuation, pre and post hospital patient transport, transfer
Michigan equipment, temperature management devices, associated
49002 hospital furniture, and stand-alone software for medical use;
USA including installation.
DUNS Number: 07-847-0558
Stryker Medical Design and Development of medical/surgical beds, stretchers,
6938 Elm valley Drive mattresses, building evacuation, pre and post hospital patient
Kalamazoo transport, transfer equipment, temperature management
Michigan devices, associated hospital furniture, and stand-alone software
49009 for medical use.
USA
DUNS Number: 07-847-0558

Original Registration Date: 2016-03-23 Effective Date: 2018-10-05 Expiry date: 2021-10-16

Page: 2 of 2

This certificate remains the property of BSI and shall be returned immediately upon request.
To be read in conjunction with the scope above or the attached appendix.

Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA
A Member of the BSI Group of Companies.

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