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ME Include



Declaration of Conformity

 

This declaration of conformity is issued under the sole responsibility of 

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SRN: 

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herewith declares that the

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​ consisting in
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​ and
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Basic UDI-DI: 
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EMDN Code:
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 to which this certificate refers

is in conformity with the Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017. 

According to

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​ of annex VIII of Council Regulation 2017/745 (2017) the
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​ is a
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​ medical device.
The conformity assessment procedure has been performed according to Annex IX.



Notified Body involved in the conformity assessment procedure:

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​, Notified Body number: 
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Identification of the certificate or certificates issued:

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Validity: This declaration of conformity ceases to be valid with the issue of a new declaration of conformity or withdrawal, as well as with the expiry of the certificates issued by the notified body.









Place, Date                                                                                                 

                                                                       Name / Signature