mdd-1
DESCRIPTION
http://www.kiranxray.com/certificate/MDD-1.pdfTRANSCRIPT
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.
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