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,
SRN: DK-MF-000021885
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
Gepard rollator
– item no. 312401-04+06+07+08
Gepard rollator HD
– item no. 312405
REF / item no.
312401
312402
312403
312404
312405
UDI-DI
5740001411218
5740001411225
5740001411270
5740001411287
5740001411232
BASIC-UDI-DI
57400014GEPARD93
REF / item no.
312406
312407
312408
UDI-DI
5740001411263
5740001411317
5740001411324
BASIC-UDI-DI
57400014GEPARD93
ACCESSORIES LIST
Item nr.
Accessories item nr.
03+04
312340, 312315, 31232E, 312321, 312322, 312325, 312329, 312332, 21233I, 21233J, 312337, 312338, 312342,
312347, 312355, 312364, 312365, 312368, 31236A, 31236B, 312321
312402
312340, 312315, 31232E, 312321, 312322, 312325, 31232J, 21233I, 21233J, 312337, 312338, 312355, 312332,
312347, 312364, 312365, 312368, 31236A, 31236B, 312321
312405
312340, 312315, 31232E, 312321, 312322, 312326, 312329, 21233I, 21233J, 312337, 312338, 312355, 312332,
312349, 312364, 312367, 312368, 31236A, 31236B, 312321
7+8
312340, 312315, 31232E, 312321, 312322, 312325, 312329, 312342, 312337, 312338, 312355, 312332, 312334,
312335, 312347, 312364, 312365, 312368, 31236A, 31236B, 312321
Harmonized norms used during conformity estimation:
PN-EN ISO 11199-2:2005; EN ISO 14971:2012, EN 1041:2009
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
Vid oförutsägbara och oavsiktliga händelser eller om det misstänks att det finns brister, misslyckanden eller fel i
produkten, skall kontakteras återförsäljaren eller Mobilex A/S
EU2017/745 for Medical Equipment
(über Medizinprodukte / for medicinalprodukter / per dispositivi medici / for medicinalprodukter)
Thomas Nygaard Christensen
Managing Director
/Geschäftsführer/
Adm. Direktør/Amministratore unico/
Verkställande Direktör
Mobilex A/S
Skanderborg, 26-04-2022
................................................
Signature/Unterschrift/Underskrift/firma
Rev. 27.04.22
23 - 24
UM-312401-08-MULTI26042022.odt
D
o
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