Oximeter in the European Union belongs to Class IIa medical devices, Class II products need to be involved in the EU announcement of the agency to issue certificates. Enterprises need to complete the CE certification documents and submit them through the audit before the system audit, and ultimately get the CE and system certificates in line with EU standards. The CE certification of oximeter needs to meet the EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR).
Category IIa to do CE certification must be a bulletin number of organizations involved, that is to say, it must be a NB organization to issue a certificate.
CE certification of oximeter need to do three projects, EMC project, LVD project biocompatibility of the three projects, the test standard based on EN60601-1-2, EN60601-1, EN60601-1-11, EN60601-2-61, ISO10993.5, ISO10993.10 standards, need 4-6 weeks.
Article source: nail oximeter CE certification how to do