Mobilex A/S
Grønlandsvej 5
DK-8660 Skanderborg
www.mobilex.dk
Declaration of Conformity (CE)
(Konformitätserklärung / Konformitetserklæring / Dichiarazione di conformità/Konformitetsförklaring)
Mobilex A/S, Grønlandsvej 5, DK-8660 Skanderborg, Denmark,
SRN: DK-MF-000021885
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
Dolphin wheelchair, Aluminium
REF / item no.
271340
271344
271348
271351
271354
271357
UDI-DI
57400014
15032
5740001
415049
574000141
5056
574000141
5063
57400014
15070
57400014
15087
BASIC-UDI-DI
57400014DOLPHINET
Dolphin wheelchair with drum brake, Aluminium
REF / item no.
271440
271444
271448
271451
271454
271457
UDI-DI
57400014
15094
5740001
415100
574000141
5117
574000141
5124
57400014
15131
57400014
15148
BASIC-UDI-DI
57400014DOLPHINET
ACCESSORIES LIST
Item no.
Accessories item no.
271340
271082, 271085, 271086, 271075, 271A81, 271A82, 27840H, 271645, 271649
271344
271082, 271085, 271086, 271075, 271A83, 271A84, 27844H, 271646, 271649
271348
271082, 271085, 271086, 271075, 271A85, 271A86, 27848H, 271647, 271650
271351
271082, 271085, 271086, 271075, 271A87, 271A88, 27851H, 271648, 271650
271354
271082, 271085, 271086, 271075, 27854H
271357
271082, 271085, 271086, 271075, 27857H
271440
271082, 271085, 271086, 271075, 271A81, 271A82, 27840H, 271645, 271649
271444
271082, 271085, 271086, 271075, 271A83, 271A84, 27844H, 271646, 271649
271448
271082, 271085, 271086, 271075, 271A85, 271A86, 27848H, 271647, 271650
271451
271082, 271085, 271086, 271075, 271A87, 271A88, 27851H, 271648, 271650
271454
271082, 271085, 271086, 271075, 27854H
271457
271082, 271085, 271086, 271075, 27857H
Harmonized norms used during conformity estimation:
PN-EN 12182, PN-EN 12183, ISO 7176-1, PN-ISO 7176-3, PN-ISO 7176-5, PN-ISO 7176-7, PN-ISO 7176-8, PN-ISO 7176-15, PN-ISO
7176-16
EU2017/745 for Medical Equipment
(über Medizinprodukte / for medicinalprodukter / per dispositivi medici)
In case of unintended incidents or suspected faults, failures or defects of the product, the dealer or Mobilex A/S
must be contacted /
Bei unbeabsichtigten Vorfällen oder vermuteten Fehlern, Ausfällen oder Defekten des Produkts muss der Händler oder Mobilex A/S
kontaktiert werden /
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 /
In caso di incidenti involontari, di sospetti di guasti, malfunzionamenti o difetti del prodotto, è necessario contattare il rivenditore o
la Mobilex A/S./
I händelse av olyckshändelser eller om man misstänker att det finns fel, brister eller defekter i produkten måste återförsäljaren
eller Mobilex A/S kontaktas.
Thomas Nygaard Christensen
Managing Director
Geschäftsführer / Adm. Direktør / Amministratore delegato
Mobilex A/S
Skanderborg, 29-04-2022
……...…...................................................
Signature/Unterschrift/Underskrift/Firma
Rev. 04-22
46/48
UM-Dolphin-Barracuda-MULTI-29042022
D
o
C