Dewert User Manual Heavy-Weight Tables – Updated 11.2021/3 MDR Page 12 of 14
10. Declaration of Conformity
EU Declaration of Conformity for medical devices
Manufacturer:
K.H. DEWERT GmbH
Vollmestr. 7
D-33649 Bielefeld
SRN:
DE-MF-000005967
Product:
Heavy-weight table
Model designation*:
7209E, 7255E
208, 209
Basic-UDI-DI:
4063907KHDewertELiegenE4
4063907KHDewertLiegenP2
Classification:
Active medical device
Class 1 medical device according to
Annex VIII, Chapter III, rule 1 (No. 4.1)
and rule 13 (No. 6.5) of Regulation (EU)
2017/745.
Non-active medical device
Class 1 medical device according to
Annex VIII, Chapter III, rule 1 (No. 4.1)
of Regulation (EU) 2017/745.
* 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).
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,
occupational thera
py 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 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, 02 November 2021
K.H. DEWERT GmbH
Management
