mbnet Engineering ergo basic Mode D'emploi page 26

ergo basic
EC AND MANUFACTURER'S DECLARATION OF CONFORMITY
Manufacturer's Name:
Business Address:
Medical Device(s):
Erklärt hiermit in alleiniger Verantwortung, dass die Medizinprodukte der Klasse I – gemäß Anhang, auf die sich
diese Erklärung bezieht, übereinstimmen mit den Bestimmungen der Richtlinie des Rates 93/42/EWG (2007/47/
EG). Die Medizinprodukte sind konform mit den grundlegenden Anforderungen gemäß Anhang I der Richtlinie. Das
Konformitätsbewertungsverfahren wurde durchgeführt gemäß Anhang II der Richtlinie.
We declare under our sole responsibility, that the medical devices of Class I – see attached list, to which this decla-
ration relates are in conformity with the provisions of the Council Directive 93/42/EEC (2007/47/EC). The medical
devices are in conformity with the essential requirements of Annex I of the EEC directive. The conformity assess-
ment procedure was performed according to Annex II of the EEC directive.
Nous déclarons sous notre seule responsabilité que les dispositifs médicaux de la Classe I – conformément au do-
cument ci-joint, auxquels se réfère cette déclaration sont conforme avec les dispositions de la Directive du Conseil
93/42/CEE (2007/47/CE). Les dispositifs médicaux sont conformes aux exigences essentielles de l'annexe I de la
directive. La procédure d'évaluation de la conformité a été effectuée conformément à l'annexe II de la directive.
Con la presente si dichiara sotto la sola responsabilità che i dispositivi medici di classe I - secondo l'allegato a
cui si riferisce la presente dichiarazione - sono conformi alle disposizioni della direttiva 93/42/CEE del Consiglio
(2007/47/CE). I dispositivi medici sono conformi ai requisiti essenziali secondo l'allegato I della direttiva. La proce-
dura di valutazione della conformità è stata effettuata secondo l'allegato II della direttiva.
Applied harmonized standards are listed in the Essential Requirements Checklist of the medical devices.
This declaration of conformity is valid until:
Authorised Signatories:
______________________________
Manuel Bucher
General Manager
Regensdorf/Switzerland 28.03.2020
page 26
Mode d'emploi
EGKONFORMITÄTSERKLÄRUNG
CE DÉCLARATION DE CONFORMITÉ
CE DICHIARAZIONE DI CONFORMITÀ
mbnet Engineering GmbH
OT Callenberg, Kirschauer Strasse 37a, D-02681 Schirgiswalde-Kirschau
ergo basic, See attached list
25.05.2021