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We here with certify
that the design and construction for our products in the form
in which they are brought into commercial traffic are in
compliance with the applicable provisions of „Guideline
93/42 of the Council of the EC Relating to Medical Products
Dated 14 June, 1993“ and that the CE-symbol has been affixed
to same by us in accordance with appendage VII thereof.
Any and all
modifications to products that have not been expressly
approved by us shall invalidate the above certification. |