Declaration of Conformity

This declaration of conformity is issued under the sole responsibility of .

SRN: 

herewith declares that the

consisting in and
Basic UDI-DI: 
EMDN Code:

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

Notified Body involved in the conformity assessment procedure:

, Notified Body number: 

Identification of the certificate or certificates issued:

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.