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5.

Manufacturers shall ensure that instruments which they have placed on the market bear a type, batch or serial number or other element allowing their identification, as set out in Annex III. For the instruments intended to be used for the applications listed in points (a) to (f) of Article 1(2), manufacturers shall affix the inscriptions provided for in point 1 of Annex III. For the instruments not intended to be used for the applications listed in points (a) to (f) of Article 1(2), manufacturers shall affix the inscriptions provided for in point 2 of Annex III. Where an instrument which is intended to be used for any of the applications listed in points (a) to (f) of Article 1(2) includes, or is connected to, devices which are not used or intended to be used for the applications listed in points (a) to (f) of Article 1(2), manufacturers shall affix to each of those devices the restrictive use symbol as provided for in Article 18 and in point 3 of Annex III.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.