This page provides the Safety and Performance Information of Nihon Kohden products as per the requirements defined in the Section 23.1 of Annex I of the EU MDR: Medical Device Regulation 2017/745/EU, and Section 20.1 of Annex I of EU IVDR: In Vitro Diagnostic Medical Device Regulation 2017/746/EU, as well as the Operator’s Manuals for IVD reagents.
This Safety and Performance Information is an extract from the general and safety information sections of the most recent edition of the Operator's Manual or Installation Guide. Therefore, the contents of your Operator's Manual or Installation Guide may differ from those provided on this page. For detailed operating procedures, follow the instructions of your Operator's Manual or Installation Guide.
Safety and Performance Information for IVD reagents can be found in the Operator’s Manuals for those products, which are provided on this page.
Please note that the products marked (SKC) are manufactured by SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORPORATION, and the rest by NIHON KOHDEN CORPORATION.
- Not all products sold in the EU are covered on this page.
- Products will be added upon issuance of a Declaration of Conformity under the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.
