Dewert User Manual 2690XLE/2695XLE/2890XL/2895XL – Updated 11.2021/3 MDR Page 13 of 15
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:
Height adjustable table
Model
designation*:
2690XLE, 2695XLE, 2890XLE, 2895XLE
2890XL/H, 2895XL/H
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.
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 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 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
