Certification

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Ramed: EXTRACT FROM MINUTES #6 of MINISTRY OF PUBLIC HEALTH OF UKRAINE

Translation from Ukrainian
Certified copy

MINISTRY OF PUBLIC HEALTH OF UKRAINE

COMMITTEE FOR NEW MEDICAL EQUIPMENT

EXTRACT FROM MINUTES No.6

Of the meeting of presidium of the Committee for New Medical Equipment of Ministry of Public Health of Ukraine dated 30.06.1999.

4.15. Having heard the report about:

Possibility of acceptance of “Medical and Diagnostic Apparatuses RAMED EXPERT” designed by “RAMED” Centre of Radiophysical Methods of Diagnosis and Therapy, Dnipropetrovsk.

Medical participating designer – Dnipropetrovsk State Medical Academy (Anatomy Department)

DECIDED:

On the grounds of submitted documents, expert advice and taking into account satisfactory results of:

  • engineering tests carried out by “Politekhmed” Ukrainian State Association;
  • toxicological and hygienic expert examination carried out by Institute of High Molecular Compounds Chemistry of National Academy of Sciences of Ukraine;
  • medical tests carried out by Institute of Pediatrics, Obstetrics and Gynecology of Academy of Medical Sciences of Ukraine, Dnipropetrovsk State Medical Academy (Department of Propedeutics of Internal Diseases), Institute of Gerontology of Academy of Medical Sciences of Ukraine (Ukrainian Rehabilitation Centre);

to approve:

  • technical documentation;

to consider it possible:

  • to use "Medical and Diagnostic Apparatuses RAMED EXPERT" in medical practice in the territory of Ukraine and its full-scale production;
  • to enter in the State Register of Medical Purpose Products of Ukraine.
Acting Head
of the Committee for New Medical Equipment
of Ministry of Public Healt of Ukraine:
Signature Ye. V. Chorny
Head of the Special-Purpose Commission for
Medical Equipment and Apparatuses:
Signature O. M. Bakharyev

Official Seal: Ministry of Public Healt of Ukraine. Committee for New Medical Equipment. Kyiv.

Reverse side:
June 6, 2000 I, Sydorevych V. A., State Notary of the First Dnipropetrovsk State Notary Office hereby certify that this is a true copy (photocopy)
Recorded in the Register under №.62985
State duty exacted 0,17 grn.
State Notary: Signature
Official Seal: Ministry of Justice of Ukraine – First Dnipropetrovsk State Notary Office

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see reverse side


Ramed: Registration Certificate

Translation from Ukrainian
Certified copy

MINISTRY OF PUBLIC HEALTH OF UKRAINE

COMMITTEE FOR NEW MEDICAL EQUIPMENT

Ukraine, 252021, Kyiv

Tel. 559 03 18


Grushevskogo St, 7
Series MZ REGISTRATION CERTIFICATE No. 783/99 No.000909

Outgoing No.558-B
of 14.07.99

This document is issued to
“RAMED” Center of Radiophysical Methods of Diagnosis and Therapy, Dnipropetrovsk

to certify that
in accordance with the order established by Ministry of Public Health of Ukraine
the product

Medical and Diagnostic Apparatuses RAMED EXPERT

has passed the test and by Order No.171 of 14.07.99 of Ministry of Health of Ukraine
is entered in the State Register of Medical Purpose Products permitted to use in medical practice in Ukraine under No.783/99

This Registration Certificate is a single and compulsory document which grants the right to use this product in medical practice in Ukraine.

Deputy Minister: Signature A.P. Kartysh

Official Seal: Ministry of Public Health of Ukraine

Reverse side:
June 6, 2000 I, Sydorevych V.A., State Notary of the First Dnipropetrovsk State Notary Office hereby certify that is a true copy (photocopy)
Recorded in the Register under No.62987
State duty exacted 0,17 grn.
State Notary: Signature
Official Seal: Ministry of Justice of Ukraine – First Dnipropetrovsk State Notary Office

.=======================

I do hereby certify that the above is a true translation of the original document certified copy in the Ukrainian Language

Translator
Certificate of State
Registration No.001111
of 10. 07. 97
Kostyrya V.V.

see reverse side