Chapter 2 Safety Information
SA-90 Instructions for Use
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2.9 Notice to the user
For a patient or user or third party in the European Union and in countries with identical regulatory regime (Regulation
2017/746/EU on In vitro Diagnostic Medical Devices); if, during the use of this device or as a result of its use, a
serious incident has occurred, please report it to the manufacturer and/or its authorized representative in the
European Union and to your national competent authority.
Reports to the authorized representative in the European Union, Sysmex Europe GmbH, must be sent by email to:
vigilance@sysmex-europe.com, or by post to Sysmex Europe GmbH, Bornbarch 1, 22848 Norderstedt, Germany.
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