In 1998, we got the certificate of ISO9002 & EN46002
from TUV Product Service GmBH, Germany, a well- known Notify Body in the
world. In 2004, we received the certificate of ISO13488 & EC 93/42EEC.
In 2005 we passed the audit of ISO13485:2003, a professional requirement
for medical devices. In 2009 we passed the audit of EN ISO 11135-1 for ETO
sterilization. In 2017 we got the certificate of EN ISO 17665-1 for steam
sterilization. Meanwhile, we also passed the FDA factory audit.