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xoid_6&8 Disc Disp X4130C_1 13/06/2018 10:12 Page 8
Serious Incidents
Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the
relevant regulatory authority in which the user and/or the patient is established.
Symbol Legend
Symbol
Revision Information
Version
Date of issue and modifications introduced
1.0
2022-07-08. New document
Definition
Catalogue number
In Vitro Diagnostic Medical Device
Batch Code
Temperature limitation (storage
temp.)
Consult
instructions for use or consult
electronic
instructions for use
Manufacturer
Authorized representative in the
European Community/
European Union
European Conformity Assessment
UK Conformity Assessment
Unique device identifier
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