Mobilex A/S
Grønlandsvej 5
DK-8660 Skanderborg
www.mobilex.dk
Declaration of Conformity (CE)
(Konformitätserklärung / Konformitetserklæring / Dichiarazione di conformità)
Mobilex A/S, Grønlandsvej 5, DK-8660 Skanderborg, Denmark,
Hereby declare under our sole responsibility as a legal manufacture
r 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
Wheelchair cushion with incontinence covers and friction bottom
PU foam Item no.:
278372, 278373, 27840N, 278402, 27840P, 27842N, 278422, 27842P, 27845N, 278452, 27845P,
27847N, 27847P, 27850N, 27850P
PU foam and adjustable
in depth Item no.:
27840H, 27842H, 27844H, 27848H, 27851H, 27854H, 27857H
Two-layer foam. Top layer from viscoelastic foam Bottom layer from PU foam
Item no.:
27840Q, 278407, 27840R, 27842Q, 278427, 27842R, 27842S, 27845Q, 278457, 27845R, 27845S,
27845F, 27847Q, 27847R, 27850Q, 27850R, 27855R
High density viscoelastic
foam Item no.:
27840C, 27842C, 27845C
ACCESSORIES LIST
Harmonized norms used during conformity estimation:
PN-EN 12183:2014; PN-EN 12182:2012; ISO 7176-part 8, 16; PN-EN 14971:2012, PN-EN 1041:2009
EU2017/745 for Medical Equipment
(über Medizinprodukte / for medicinalprodukter /
del Consiglio Europeo
)
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
Mobilex A/S
Skanderborg, 11-01-2022
………….................................................
Signature/Unterschrift/Underskrift/firma
Rev. 01/22
Page 15 of 16
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