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In 2004, we received the certificate of IS013485 & EC 93/42EEC. In 2005 we passed the audit of IS013485, a professional requirement for medical devices. In 2009 we passed the audit of EN IS0 11135‐1 for ETO sterilization. In 2017 we got the certificate of EN IS0 17665‐1 for steam sterilization. Meanwhile, we also passed the FDA factory audit.

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