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CERTIFICATE OF ATTESTATION OF' TECHNICAL FILING The documentation included in the ./ Technical File Construction Technical File Design Dossier Of the products listed in, ANNEX I Which are manufactured and delivered to market by; . ' KIRAN MEDICAL SYSTEMS 0-134 T. T.C. Industrial Area Village Shirvane, PO Nerul, Navi Mumbai 400 706,Maharashtra, INDIA are in compliance with MOO 93/42 EEC & MOO 07/47 EEC As described in the CE Technical File Overview Report No/: 11/TCF/MDD/KIRAN/BOl This certificate only refers to the technical file and/or Construction Technical File and/or Design File of ANNEX I for "CE Labellnq" supplied to Kalitest for its evaluation and does not imply the assessment of each manufactured' unit of the same or different models, the manufacturing system, the examination methods and affirmation of test results. This certificate shall be only valid in case in the relevant "User's Guide" and "CE Declaration of Conformity" of the product are written in the official language of the distribution country . Kalitest Certification and Training Services Inc : Signed:~ Please verify the validity of this certificate with the serial number of 9544768 from the web site of www.kalitest.com.tr KALITEST BELGELENDiRME VE EGiTiM HizMETLERi LiMiTED ~iRKETI Akatlar Mahallesi Hare Sokak. 2. soltas Evleri G-10 No:91. Levent! iSTANBUL Tel: 0212 269 37 41-42-43 Faks: 02122693744 Certificate No TCF-MDD-1000 First 28.02.2011 Registration Date Period of registration: 5 years Certificate Date: 28.02.2011 28.02.2016 Company's conformity with KALiTeST Certificate Regulations and the result of the surveillance audits which will be carried out at least once in a year.

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Page 1: MDD-1

CERTIFICATE OF ATTESTATION OF'TECHNICAL FILING

The documentation included in the

./ Technical FileConstruction Technical FileDesign Dossier

Of the products listed in, ANNEX I

Which are manufactured and delivered to market by;. '

KIRAN MEDICAL SYSTEMS

0-134 T. T.C. Industrial Area Village Shirvane, PO Nerul,Navi Mumbai 400 706,Maharashtra, INDIA

are in compliance with

MOO 93/42 EEC& MOO 07/47 EEC

As described in the CETechnical File Overview Report No/: 11/TCF/MDD/KIRAN/BOl

This certificate only refers to the technical file and/or Construction TechnicalFile and/or Design File of ANNEX I for "CE Labellnq" supplied to Kalitestfor its evaluation and does not imply the assessment of each manufactured'unit of the same or different models, the manufacturing system, theexamination methods and affirmation of test results.

This certificate shall be only valid in case in the relevant "User's Guide"and "CE Declaration of Conformity" of the product are written in theofficial language of the distribution country .

Kalitest Certification and Training Services Inc :

Signed:~

Please verify the validity of this certificate with the serial number of 9544768 from the web site of www.kalitest.com.tr

KALITEST BELGELENDiRME VE EGiTiM HizMETLERi LiMiTED ~iRKETIAkatlar Mahallesi Hare Sokak. 2. soltas Evleri G-10 No:91. Levent! iSTANBUL Tel: 0212 269 37 41-42-43 Faks: 02122693744

Certificate No TCF-MDD-1000

First 28.02.2011Registration Date

Period of registration: 5 years

Certificate Date: 28.02.2011

28.02.2016

Company's conformity with KALiTeSTCertificate Regulations and the result of thesurveillance audits which will be carried outat least once in a year.

Page 2: MDD-1

KALiTEST BELGELENDiRME VE EGITiM HlzMETLERi LiMiTED ~iRKETiAkatlar Mahallesi Hare Sokak. 2. Soltas Evleri G-10 No:91. Leventl iSTANBUL Tel: 0212 269 37 41-42-43 Faks: 0212 269 37 44

ANNEX I

Product Category Product detailsTechnical file

number

X-ray cassette X-ray cassette

X-ray cassette with

identification windowMDDjTFjOS Rev.O

Deep cassette (Grid cassette)

Mammography cassette

Intensifying Intensifying screenScreen Dental screen .

Gradient screen MDDjTFj02 RevOl

(Gradual screen)

Mammography screen

Anti scatter gridMDDjTFj03 Rev.O

Computed Radiographic Systems &. Equipment MDDjTFj04 Rev.O

Radiation Thyroid shieldprotection appareland Accessories Gonad shield

Ovarian shield

, Patient shield

Dental apron (Panoramicapron) MDDjTFj08 Rev.O

Mini apron (Patient apron)

Cassette cover

Cassette half cover

Radiation guardHead qear (head can)

Radiation Protection Shields MDDjTFj07 Rev 0

Storage System for Radiation Protection Apparel MDDjTFj06 Rev 0