Werbung
Verfügbare Sprachen
Verfügbare Sprachen
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 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
Buffalo Rollator HD
REF / item no.
312305
UDI-DI
5740001411102
BASIC-UDI-DI
ACCESSORIES LIST
Item nr.
Accessories item nr.
312305
312340, 312316, 312320, 312322, 312331, 312349, 312366, 312367, 312368, 31236A,
31236B, 312321, 312337, 312338, 31233J, 31233I, 312329
312307
312340, 312316, 312320, 312322, 312331, 312349, 312366, 312367, 312368, 31236A,
31236B, 312321, 312337, 312338, 31233J, 31233I, 31232J
312385
312340, 312316, 312320, 312322, 312331, 312349, 312366, 312367, 312368, 31236A,
31236B, 312321
312387
312340, 312316, 312320, 312322, 312331, 312349, 312366, 312367, 312368, 31236A,
31236B, 312321, 31232J
Harmonized norms used during conformity estimation:
PN-EN ISO 11199-2:2008; 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
EU2017/745 for Medical Equipment
(über Medizinprodukte / for medicinalprodukter / per dispositivi medici / for medicinalprodukter)
Thomas Nygaard Christensen
Managing Director/Geschäftsführer/
Adm. Direktør/Amministratore unico
Mobilex A/S
Skanderborg, 18-05-2022
Serial number:
Rev. 18.05.22
312307
5740001411126
5740001411331
57400014BUFFALOB7
20 - 20
SRN: DK-MF-000021885
312385
312387
5740001411348
................................................
Signature/Unterschrift/Underskrift/firma
UM-312305-07-MULTI_18052022.odt
Werbung
