25.02.2020 Dear partners!
Today in the medical community, there is a problem of misunderstanding which documents indicate that the equipment is medical and can be used in medical institutions.
There are requirements prohibiting the use of household non-medical equipment in medical institutions.
It is not enough to define equipment as "medical" in the instructions for use!
There are several non-medical Technical regulations that do not relate to medical devices !!!
We advise you to pay attention to the presence of the Declaration and Certificate of Compliance with the requirements of the Technical Regulations for medical devices approved by the Decree of the Cabinet of Ministers of Ukraine No. 753 and No. 754 of 02.10.2013, when purchasing equipment and disposables.
ONLY THESE DOCUMENTS confirm that the equipment, disposables are medical and are approved for use in medical enterprises.
The authorized representative of the manufacturer must go through the conformity assessment procedure, obtain a Certificate of Conformity and make a Declaration of Conformity (it depends on the safety class of the medical device).
If you have questions regarding the above information, our highly qualified specialists know the answer.
Sincerely, Ledum Ltd