Declaration Of Conformity (Ce) - Mobilex Dolphin Gebrauchsanleitung

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
Barracuda wheelchair with adjustable back, Aluminium
REF / item no. 271840
UDI-DI 5740001
441031
BASIC-UDI-DI
Barracuda wheelchair with drum brake, Aluminium
REF / item no.
UDI-DI
BASIC-UDI-DI
ACCESSORIES LIST
Item no. Accessories item no.
271840 271082, 271085, 271086, 271075, 271A81, 271A82, 27840H, 271645, 271649
271844 271082, 271085, 271086, 271075, 271A83, 271A84, 27844H, 271646, 271649
271848 271082, 271085, 271086, 271075, 271A85, 271A86, 27848H, 271647, 271650
271851 271082, 271085, 271086, 271075, 271A87, 271A88, 27851H, 271648, 271650
272044 271082, 271085, 271086, 271075, 271A83, 271A84, 27844H, 271646, 271649
272048 271082, 271085, 271086, 271075, 271A85, 271A86, 27848H, 271647, 271650
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
Rev. 04-22
271844 271848
57400014 5740001
41048 441055
57400014BARRACUDATB
272044
5740001441031 5740001441048
57400014BARRACUDATB
271851
574000144
1062
272048
45/48
...............................................................
Signature/Unterschrift/Underskrift/Firma
UM-Dolphin-Barracuda-MULTI-29042022