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 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 CE marking has been affixed on the product according to Annex V of the Regulation (EU) 2017/745.
PRODUCT LIST
REF / item no.
30610L
30612L
30616L
30620L
30624L
UDI-DI
5740001430004
5740001430011
5740001430028
5740001430035
5740001430042
REF / item no.
30628L
30632L
30636L
30640L
30644L
UDI-DI
5740001430059
5740001430066
5740001430073
5740001430080
5740001430097
REF / item no.
30648L
306040
306041
306042
306060
UDI-DI
5740001430103
5740001430110
5740001430127
5740001430134
5740001430141
REF / item no.
306061
306062
306080
306081
306082
UDI-DI
5740001430158
5740001430165
5740001430172
5740001430189
5740001430196
REF / item no.
306100
306101
306102
306120
306121
UDI-DI
5740001430202
5740001430219
5740001430226
5740001430233
5740001430240
REF / item no.
306122
306160
306161
306162
306200
UDI-DI
5740001430257
5740001430264
5740001430271
5740001430288
5740001430295
REF / item no.
306201
306202
306240
306241
306242
UDI-DI
5740001430301
5740001430318
5740001430325
5740001430332
5740001430349
REF / item no.
306280
306281
306282
306320
306321
UDI-DI
5740001430356
5740001430363
5740001430370
5740001430387
5740001430394
REF / item no.
306321
306322
306360
306361
306362
UDI-DI
5740001430394
5740001430400
5740001430417
5740001430424
5740001430431
REF / item no.
306400
306401
306402
306440
306441
UDI-DI
5740001430448
5740001430455
5740001430462
5740001430479
5740001430486
REF / item no.
306442
306480
306481
306482
306520
UDI-DI
5740001430493
5740001430509
5740001430516
5740001430523
5740001430530
REF / item no.
306521
306522
306560
306561
306562
UDI-DI
5740001430547
5740001430554
5740001430561
5740001430578
5740001430585
REF / item no.
306600
3066601
306602
UDI-DI
5740001430592
5740001430608
5740001430615
ACCESSORIES LIST
Item no
Accessories item no.
30610L-
306602
306904: Jigsaw blade for rubber ramp
12: Double adhesive tape
306905: Degreaser for removal of glue
306910: Mounting set for rubber ramp zinc plated
Harmonized norms used during conformity estimation:
PN-EN ISO 11199-3:2008; EN ISO 14971:2011, EN 1041:2009
Rev. 10.05.22
23 - 24
UM-306040-306601-MULTI10052022.odt
D
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C