Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 14 of 16
10. Declaration of Conformity
EU Declaration of Conformity for medical devices
Manufacturer:
K.H. DEWERT GmbH
Vollmestr. 7
D-33649 Bielefeld
The product:
Height adjustable table
Model designation:
DX1 series
– models:
1000E; 1000/H
1030E; 1030/H
1050E; 1050/H
1090/H; 1093/H; 1095/H
The numerical codes -00, -03, -04 appended to the individual model designation only indicate the colour of the frame
(-00 = white frame, -03= white aluminium frame, -04= grey aluminium frame).
Basic UDI-DI:
4063907KHDewertLiegenP2
SRN:
DE-MF-000005967
Intended purpose:
The table is used for the ideal positioning of patients for the purpose of curative and disease treatment,
examination, massage and health therapy.
Table operation and patient positioning on the table may only be performed by professionally trained persons
who have been instructed in its use or who, through experience with other similar medical devices, have
knowledge of its proper use, taking into account possible hazards.
Equipped with the options of movability (not wheel-lifting/fixing mechanism), side guards and push handle, the
intended purpose of the table is extended and also provides for the ideal positioning of patients for the
purpose of transport to pre-treatment or post-treatment locations. Patient positioning during the recovery
phase after a medical procedure is also permitted under supervision.
Otherwise, the device must only be moved within the room for cleaning or patient access.
This device has been developed exclusively for use indoors and in normal ambient conditions and can be
used in the following areas: laboratories, medical practices, examination and treatment rooms, hospitals,
clinics, physiotherapy practices, occup
ational therapy centres and doctors’ surgeries.
This table is not classed as surgical furniture and must, therefore, not be used for surgical purposes.
complies with the relevant provisions of Regulation (EU) 2017/745, Article 19, Annex IV (Class 1
according to Annex VIII, Chapter III, No. 4.1 of 5 April 2017).
We hereby declare conformity with the aforesaid directive.
As the manufacturer, we bear sole responsibility for issuing this EU Declaration of Conformity.
Mark:
Bielefeld/Germany, 26 May 2021
K.-H. DEWERT GmbH
Management
