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EC DESIGN-EXAMINATIONCERTIFICATE

Number: 2162627DE06

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

Manufacturer:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

For the product

Straumann® GBR MembraneStraumann® Jason Membrane

Documents, that form the basis of this certificate:^'

Certification Notice 2162627CN, initially datedlO July 2ai^<CE Marking of Conformity 2162627CE06Addendum, initially dated 15 November2016

/////////ftDEKRA hereby declares that the design of the product(s) fallingwithin^e'pfridi^rtttateyo^.'^ntioned above, fulfilsthe relevant provisions of'BesluitMedische Huipmiddeien\ theDutch,1:ranspositioni3ft^(^^ 93/42/EE(of June 14, 1993 concerning Medical devices, including all subsequent'amehdments./bSsed'bn an examination in //accordance with Annex II (4) of this Directive. The manufacturer has JmRlementect a, quality assurance system for the/above mentioned product category in accordance tothe provisions of Annex II (4)ofGouhcil^ 93/42/EEC ofJune 14, 1993 and is subject to periodical surveillance. Additionally, DEKRA hereby declares .that the manufacturerfulfils the relevant provisions as specified in Annex I of Commission Regulation 722/2012 of 8 August, 2012 concerningmedical devices manufactured utilising tissue of animal origin.The necessary information and the reference to the relevant documentation, of the products concerned and theexaminations and assessments performed, are stated in the Certification Notice which forms an integrative part of thiscertificate.

This certificate is valid until: 18 June 2019Issued for the first time: 15 November 2016Revised: 25 January 2017

DEKRA Certification B.V.

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drs. G.J. ZoetbroodManaging Director

ing. A.A.M. LaanCertification 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 NetherlandsT+31 889683000 F+31 88 96 83100 www.dekra-certification.com Company registration 09085396

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ADDENDUM

Belonging to certificate: 2162627DE06

EC DESIGN-EXAMINATIONMEDICAL DEVICES

Straumann® GBR MembraneStraumann® Jason Membrane

Issued to:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

This certificate covers the following

15 x 20 mm20 x 30 mm30 x 40 mm

Initial date: 15 November 2016

drs. G.J. ZoetbroodManaging Director

ing. A.A.M. LaanCertification 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 NetherlandsT +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396