Quality/ Environmental Management

Certificates, CE declarations, information

The Ottobock manufacturing sites are certified according to DIN EN ISO 13485. The current certificates that document the effective introduction and maintenance of QM systems can be downloaded here. The CE declaration of conformity confirms the compliance of the Ottobock products with the statutory requirements under the medical device regulation 2017/745. Relevant documents regarding the Ottobock manufacturing sites can be found on this page.

Safety data sheets

This download provides a database including all current safety data sheets, operating instructions and list of substances, as well as further information.

Note:
Please download the zip-file locally to your PC and unzip the file. The unzipped file contains the “sumdat” folder with the SDS-Database. Please don’t open the “sumdat” folder without unpacking the zip-file. It leads to problems opening the database.

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Manual

Download (PDF 430.36 KB)
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Database for safety data sheets

Download (ZIP 36.12 MB)

If you have any questions about the content of the material safety data sheets, please contact the department safety and environmental (Arbeitssicherheit@ottobock.de).

REACh regulation
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Information obligation according to article 33 in REACh regulation (EG Nr. 1907/2006) Otto Bock Mobility Solutions GmbH

Download (PDF 110.67 KB)
RoHs-Declaration of Conformity
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RoHs-Declaration of Conformity Ottobock SE & Co. KGaA

Download (PDF 163.27 KB)
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RoHS Declaration of Conformity Otto Bock Healthcare Products GmbH

Download (PDF 137.09 KB)
RoHs2 Declaration of Conformity
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RoHS2 Declaration of Conformity Otto Bock Mobility Solutions GmbH

Download (PDF 175.94 KB)
RED Declaration of Conformity Otto Bock Healthcare Products GmbH
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RED Declaration of Conformity Otto Bock Healthcare Products GmbH

Download (PDF 550.71 KB)
Declaration for materials and semi finished products of Ottobock SE & Co. KGaA
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Declaration for materials and semi finished products of Ottobock SE & Co. KGaA

Download (PDF 170.5 KB)
DIN EN ISO 13485 Quality Management System
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DIN EN ISO 13485 Quality Management System Ottobock SE & Co. KGaA

Download (PDF 564 KB)
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DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions GmbH - Effective date: 2020-07-17

Download (PDF 795.13 KB)
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DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions GmbH

Download (PDF 754.8 KB)
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DIN EN ISO 13485 Quality Management System Otto Bock Healthcare Products GmbH

Download (PDF 705.99 KB)
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DIN EN ISO 13485 Qualitätsmanagement-System Otto Bock HealthCare Deutschland GmbH

Download (PDF 691.16 KB)
CE declaration of conformity
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CE declaration of conformity Ottobock SE & Co. KGaA

PDF | 9.8 MB
Download (PDF 9.33 MB)
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CE declaration of conformity Otto Bock Healthcare Products GmbH

Download (PDF 4.56 MB)
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