Declaration of Conformity
Vendlet ApS hereby declare that the devices mentioned below comply with the Medical Device
Regulation (EU) 2017/745.
Legal manufacturer:
Vendlet ApS, Egelund 33, 6200 Aabenraa, DK
Device:
Product no. and name
6300000 VENDLET Standard
UDI-DI:
05714038001094
Basic UDI-DI:
05714038001049EU
Description:
Electromechanical turning aid for handling and turning patients
in bed.
Classification, rule:
Class I acc. to rule 1 and 13 of annex VIII in (EU) 2017/745.
The product complies with
the following standards:
EN 60601-2-52:2010 Medical electrical equipment – Part 2-52:
Particular requirements for basic safety and essential perfor-
mance of medical beds
60601-1-2:2015 Medical electrical equipment. General require-
ments for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and test
This declaration of conformity is valid from the date of signature.
Aabenraa, 02.11.2021
Peter Maindal
Director
Summary of Contents for STANDARD
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