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 . Certificate
No
28.02.2011
First Registration
Kalitest Certification and Training Services Inc :
TCF-MDD-1000
Date
Period of registration:
Signed:~
Certificate
Date:
5 years
28.02.2011 28.02.2016
Please verify the validity of this certificate with the serial number of 9544768 from the web site of www.kalitest.com.tr 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.
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
ANNEX I
Product details
Product Category
Technical file number
X-ray cassette
X-ray cassette
X-ray cassette with identification
window
MDDjTFjOS Rev.O
Deep cassette (Grid cassette) Mammography cassette Intensifying Screen
Intensifying
screen
Dental screen
.
Gradient screen
MDDjTFj02 RevOl
(Gradual screen) Mammography screen Anti scatter grid
MDDjTFj03 Rev.O
Computed Radiographic Systems &. Equipment Radiation protection apparel and Accessories
MDDjTFj04 Rev.O
Thyroid shield Gonad shield Ovarian shield
,
Patient shield Dental apron (Panoramic apron)
MDDjTFj08 Rev.O
Mini apron (Patient apron) Cassette cover Cassette half cover Radiation guard Head qear (head can) Radiation Protection Shields
MDDjTFj07 Rev 0
Storage System for Radiation Protection Apparel
MDDjTFj06
Rev 0
KALiTEST BELGELENDiRME VE EGITiM HlzMETLERi LiMiTED ~iRKETi Akatlar Mahallesi Hare Sokak. 2. Soltas Evleri G-10 No:91. Leventl iSTANBUL Tel: 0212 269 37 41-42-43
Faks: 0212 269 37 44