Mobilex A/S
Grønlandsvej 5
DK-8660 Skanderborg
www.mobilex.dk
Declaration of Conformity (CE)
(Konformitätserklärung / Konformitetserklæring / Dichiarazione di conformità / Déclaration de conformité)
Mobilex A/S, Grønlandsvej 5, DK-8660 Skanderborg, Denmark,
Hereby declare under our sole responsibility as a legal manufacturer that the product specified on the product
list below, meet the essential health and safety requirements and is in conformance with the provisions of the
Regulation (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices.
The product specified on the product list below is “technical aid for the disabled”, classified as Class I, medical
device. The classification is based on the requirements of Rule 1 of annex VIII, of the Regulation (EU) 2017/745.
The CE marking has been affixed on the product according to Annex V of the Regulation (EU) 2017/745.
PRODUCT LIST
DynaWalk
Verticalizer/Walking Frame 313001, 313002
Harmonized norms used during conformity estimation:
PN-EN ISO 11199:2005, EN ISO 14971:2012, EN 1041:2009
EU2017/745 for Medical Equipment
(über Medizinprodukte / for medicinalprodukter /
per prodotti medicinali / sur les équipments
médecaux
)
In case of unintended incidents or suspected faults, failures or defects of the product, the dealer
or Mobilex A/S must be contacted /
Ved utilsigtede hændelser eller hvis der er formodning om, at der er fejl, svigt eller mangler ved produktet skal
forhandleren eller Mobilex A/S kontaktes /
Bei unbeabsichtigten Vorfällen oder vermuteten Fehlern, Ausfällen oder Defekten des Produkts muss der
Händler oder Mobilex A/S kontaktiert werden /
In caso di incidenti involontari, di sospetti di guasti, malfunzionamenti o difetti del prodotto, è necessario
contattare il rivenditore o la Mobilex A/S.
Thomas Nygaard Christensen
Managing Director
/Geschäftsführer/
Adm. Direktør/Amministratore unico/
Directeur Général
Mobilex A/S
Skanderborg, 29-09-21
................................................
Signature/Unterschrift/Underskrift/firma
Serial number:
Rev. 29.09.21
24 - 24
UM-313001-04-MULTI_29092021.odt
D
o
C
