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Obelis O.E.A.R.C.
CE Marking Articles
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EAAR MEMBER
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ISO 9001:2001 |
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MDD 93/42/ECC Article 4.4 excerpt
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4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
for a complete copy of the Directive, click here
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