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ANNEX IV

Instrument model/Instrument (product, type, batch or serial number): Name and address of the manufacturer and, where applicable, his authorised representative: This declaration of conformity is issued under the sole responsibility of the manufacturer. Object of the declaration (identification of instrument allowing traceability; it may, where necessary for the identification of the instrument, include an image): The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared: The notified body … (name, number) performed … (description of intervention) and issued the certificate: Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature):

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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.