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We Acquired Such Important International Certificates

We acquired such important international Certificates for our oxygen concentrators, some of them get US FDA certificate.


CE (Conformité Européenne) Standard

This marking is allowed to use if the EU standard is satisfied. This acquisition is required for product sales in the EEA (European Economic Area), Turkey, and Switzerland. Nidec has already received the CE certification by German TUV, and declared the CE.


TUV Authentication (Technischer Überwachungs Verein)

This is the German safety standard pronounced as "tuf". It is authorized when the European Information Technology Equipment Safety Standard, EN-60950, is acquired from the Technical Inspection Association (TUV) certified by the German government. This is the fairly independent third-party inspection institution, and renowned as the strict inspection criteria.


IEC (International Electrotechnical Commission) Standard

This is the International Electrotechnical Commission standard in the field of electrical and electronic technologies, and it was established by the IEC (International Electrotechnical Commission). It is aimed to contribute to the development of technologies and to the promotion of world trade by ensuring the quality and safety of the products that meet this standard.
Nidec meets the Premium class standard. * Premium (IE3)



FDA’s regulatory authority is very broad.

 FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.