TOPCON
1 August, 2014
To whom it may concern
CE-marking on Topcon DC-4
We confirm that the TDF (Technical Document File) which we prepared for our SLIT LAMP
SL-D701 was including not only SL-D701 main unit but also its related accessories, and
based on this TDF, we have declared in the DOC (Declaration of Conformity) that the
SL-D701 is MDD (Medical Device Directive) conformed.
From the above, we officially hereby certify that any accessory for the SL-D701 including
that DIGITAL CAMERA UNIT DC-4 should be considered as fully MDD conformed
although CE-mark indication is available on the SL-D701 main unit only.
The above stated declaration is true and correct, and the contents are valid up to date.
Signatory:
i
Hiroshi Akiyama
‘Senior Manager
Quality Assurance Dept.
Eye Care Company
TOPCON CORPORATION